Table 5 Adverse events with at least 1 incident event 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 pain‡^ | 1.3 | 1.7 | -0.5 (-1.0, 0.0) |
Constipation | 2.6 | 1.9 | 0.8 (0.1, 1.4) |
Diarrhea‡ | 6.9 | 9.6 | -2.3 (-3.6, -1.0) |
Dyspepsia | 2.0 | 1.6 | 0.4 (-0.1, 1.0) |
Gastritis | 1.2 | 1.5 | -0.3 (-0.8, 0.2) |
Gastroesophageal reflux disease | 1.1 | 0.8 | 0.3 (-0.1, 0.8) |
Nausea‡ | 3.0 | 3.8 | -0.5 (-1.3, 0.3) |
Toothache | 1.2 | 1.3 | -0.2 (-0.7, 0.3) |
Vomiting‡ | 1.8 | 1.9 | 0.0 (-0.6, 0.6) |
General disorders and administration site conditions SOC | |||
Fatigue | 1.8 | 2.5 | -0.6 (-1.3, -0.0) |
Peripheral Edema | 2.4 | 2.4 | -0.0 (-0.7, 0.6) |
Infections and infestations SOC | |||
Bronchitis | 4.2 | 3.8 | 0.4 (-0.4, 1.3) |
Cellulitis | 0.8 | 1.0 | -0.2 (-0.6, 0.2) |
Gastroenteritis | 2.0 | 1.9 | 0.1 (-0.5, 0.7) |
Gastroenteritis Viral | 1.0 | 1.0 | 0.0 (-0.4, 0.5) |
Influenza | 4.5 | 5.2 | -0.7 (-1.7, 0.2) |
Nasopharyngitis | 7.7 | 7.0 | 0.9 (-0.3, 2.1) |
Pharyngitis | 1.5 | 1.4 | 0.1 (-0.4, 0.6) |
Sinusitis | 2.7 | 2.7 | 0.1 (-0.6, 0.8) |
Upper respiratory tract infection | 8.6 | 9.0 | -0.3 (-1.6, 1.0) |
Urinary tract infection | 4.1 | 4.2 | -0.2 (-1.1, 0.6) |
Viral infection | 1.1 | 0.9 | 0.2 (-0.2, 0.7) |
Injury, poisoning, and procedural complications SOC | |||
Contusion | 1.0 | 0.8 | 0.1 (-0.3, 0.5) |
Muscle strain | 0.9 | 1.0 | -0.1 (-0.6, 0.3) |
Investigations SOC | |||
ALT increased | 1.5 | 1.4 | 0.1 (-0.4, 0.6) |
AST increased | 1.0 | 1.0 | 0.0 (-0.4, 0.4) |
Blood glucose decreased | 0.5 | 1.0 | -0.5 (-0.9, -0.1) |
Blood glucose increased | 2.3 | 3.6 | -1.3 (-2.1, -0.6) |
Blood uric acid increased | 1.0 | 0.8 | 0.2 (-0.2, 0.6) |
Weight increased | 0.8 | 1.0 | -0.2 (-0.7, 0.2) |
Metabolism and nutrition disorders SOC | |||
Hyperglycemia | 1.2 | 1.4 | -0.2 (-0.7, 0.3) |
Hypoglycemia‡ | 5.2 | 12.1 | -6.8 (-8.3, -5.5) |
Musculoskeletal and connective tissue disorders SOC | |||
Arthralgia | 3.4 | 3.7 | -0.3 (-1.2, 0.5) |
Back pain | 4.3 | 4.1 | 0.1 (-0.8, 1.0) |
Muscle spasms | 1.2 | 1.5 | -0.3 (-0.8, 0.2) |
Musculoskeletal pain | 1.6 | 1.6 | -0.1 (-0.6, 0.5) |
Myalgia | 1.2 | 1.2 | -0.0 (-0.5, 0.4) |
Neck pain | 0.7 | 1.0 | -0.3 (-0.7, 0.1) |
Osteoarthritis | 1.6 | 1.1 | 0.5 (-0.0, 1.0) |
Pain in extremity | 2.8 | 2.1 | 0.7 (0.1, 1.4) |
Nervous system disorders SOC | |||
Dizziness | 2.8 | 2.7 | 0.1 (-0.6, 0.9) |
Headache | 5.8 | 5.6 | 0.4 (-0.7, 1.4) |
Hypoesthesia | 0.7 | 1.1 | -0.4 (-0.8, 0.0) |
Paraesthesia | 1.0 | 1.2 | -0.2 (-0.7, 0.3) |
Psychiatric disorders SOC | |||
Anxiety | 0.9 | 1.0 | -0.1 (-0.5, 0.3) |
Depression | 1.4 | 1.2 | 0.3 (-0.2, 0.8) |
Insomnia | 1.5 | 1.4 | 0.0 (-0.5, 0.6) |
Respiratory, thoracic, and mediastinal disorders SOC | |||
Cough | 2.7 | 2.6 | 0.0 (-0.7, 0.7) |
Oropharyngeal pain | 1.3 | 1.2 | 0.1 (-0.4, 0.6) |
Skin and subcutaneous tissue disorders SOC | |||
Rash | 1.3 | 0.9 | 0.4 (-0.1, 0.8) |
Vascular disorders SOC | |||
Hypertension | 3.6 | 3.6 | -0.1 (-1.0, 0.7) |