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† | ||
|---|---|---|---|
| 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) |
CI = confidence interval;
†100 * (number of patients with ≥ 1 event/person years of follow-up time).
* Between-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.
‡As determined by the investigator