Table 7.
Adverse events with at least 1 incident event per 100 patient-years in one or both groups
| Adverse event | Incidence rate per 100 patient-yearsa | ||
|---|---|---|---|
| Sitagliptin 100 mg | Non-exposed | Difference between sitagliptin and non-exposed (95% CI)b | |
| Gastrointestinal disorders SOC | |||
| Abdominal painc | 3.7 | 4.0 | −0.3 (−1.1, 0.4) |
| Constipation | 2.3 | 1.8 | 0.6 (0.0, 1.1) |
| Diarrhea | 6.6 | 8.4 | −1.4 (−2.5, −0.4) |
| Dyspepsia | 2.0 | 1.4 | 0.6 (0.0, 1.1) |
| Gastritis | 1.4 | 1.4 | 0.0 (−0.4, 0.4) |
| Gastroesophageal reflux disease | 1.0 | 0.7 | 0.3 (−0.0, 0.7) |
| Nausea | 2.8 | 3.2 | −0.2 (−0.9, 0.4) |
| Toothache | 1.1 | 1.3 | −0.3 (−0.7, 0.1) |
| Vomiting | 1.8 | 1.6 | 0.3 (−0.2, 0.8) |
| General disorders and administration site conditions SOC | |||
| Fatigue | 1.6 | 2.1 | −0.5 (−1.1, −0.0) |
| Peripheral edema | 2.2 | 3.0 | −0.8 (−1.4, −0.2) |
| Infections and infestations SOC | |||
| Bronchitis | 3.7 | 3.3 | 0.5 (−0.2, 1.1) |
| Gastroenteritis | 2.1 | 1.6 | 0.5 (−0.0, 1.0) |
| Influenza | 4.0 | 4.7 | −0.7 (−1.5, 0.0) |
| Nasopharyngitis | 7.3 | 7.1 | 0.4 (−0.6, 1.4) |
| Pharyngitis | 1.7 | 1.6 | 0.0 (−0.5, 0.5) |
| Sinusitis | 2.3 | 2.4 | −0.0 (−0.6, 0.5) |
| Upper respiratory tract infection | 7.8 | 8.4 | −0.5 (−1.6, 0.6) |
| Urinary tract infection | 3.9 | 4.2 | −0.3 (−1.1, 0.4) |
| Investigations SOC | |||
| ALT increased | 1.5 | 1.3 | 0.2 (−0.2, 0.7) |
| Blood glucose decreased | 0.7 | 1.3 | −0.5 (−0.9, −0.1) |
| Blood glucose increased | 2.0 | 3.1 | −1.1 (−1.8, −0.6) |
| Weight increased | 0.8 | 1.4 | −0.6 (−1.0, −0.2) |
| Metabolism and nutrition disorders SOC | |||
| Hyperglycemia | 1.4 | 1.6 | −0.3 (−0.8, 0.2) |
| Hypoglycemia | 6.7 | 13.0 | −6.3 (−7.6, −5.1) |
| Musculoskeletal and connective tissue disorders SOC | |||
| Arthralgia | 3.3 | 3.6 | −0.3 (−1.0, 0.4) |
| Back pain | 4.2 | 3.9 | 0.2 (−0.5, 1.0) |
| Muscle spasms | 1.1 | 1.3 | −0.2 (−0.6, 0.2) |
| Musculoskeletal pain | 1.5 | 1.5 | −0.1 (−0.5, 0.4) |
| Myalgia | 1.1 | 1.2 | −0.1 (−0.5, 0.3) |
| Osteoarthritis | 1.4 | 1.1 | 0.2 (−0.2, 0.6) |
| Pain in extremity | 2.6 | 2.1 | 0.5 (−0.1, 1.0) |
| Nervous system disorders SOC | |||
| Dizziness | 2.6 | 2.6 | −0.0 (−0.6, 0.6) |
| Headache | 5.8 | 5.4 | 0.5 (−0.3, 1.4) |
| Hypoesthesia | 0.7 | 1.0 | −0.4 (−0.7, −0.0) |
| Paraesthesia | 1.1 | 1.1 | −0.1 (−0.5, 0.3) |
| Psychiatric disorders SOC | |||
| Depression | 1.3 | 1.2 | 0.2 (−0.2, 0.6) |
| Insomnia | 1.4 | 1.3 | 0.1 (−0.4, 0.5) |
| Respiratory, thoracic, and mediastinal disorders SOC | |||
| Cough | 2.5 | 2.4 | 0.0 (−0.6, 0.6) |
| Oropharyngeal pain | 1.2 | 1.1 | 0.1 (−0.3, 0.5) |
| Skin and subcutaneous tissue disorders SOC | |||
| Rash | 1.2 | 0.9 | 0.3 (−0.1, 0.7) |
| Vascular disorders SOC | |||
| Hypertension | 3.4 | 3.4 | −0.1 (−0.8, 0.6) |
ALT alanine aminotransferase, SOC system organ class
a100 × (number of patients with ≥1 event/patient-years of follow-up time)
bBetween-group difference and 95% CI based on stratified analysis. Positive differences indicate that the incidence rate for the sitagliptin group is higher than the incidence rate for the non-exposed group. “0.0” and “−0.0” represent rounding for values that are slightly greater and slightly less than zero, respectively
cAbdominal pain includes abdominal pain, upper and lower abdominal pain, and abdominal and epigastric discomfort