Treatment-emergent SAEs by system organ class in the older cohort, by treatment group
| System organ class preferred term patients with one or more: . | Age ≥75 years old . | ||
|---|---|---|---|
| Sitagliptin . | Placebo . | Difference . | |
| (n = 956) . | (n = 1,023) . | (95% CI) . | |
| Neoplasms benign, malignant, and unspecified (including cysts and polyps) | 80 (8.4%) | 94 (9.2%) | −0.82 (−3.33 to 1.70) |
| Basal cell carcinoma | 11 (1.2%) | 24 (2.3%) | −1.20 (−2.44 to −0.04) |
| Squamous cell carcinoma | 5 (0.5%) | 17 (1.7%) | −1.14 (−2.18 to −0.24) |
| Squamous cell carcinoma of skin | 3 (0.3%) | 14 (1.4%) | −1.05 (−2.01 to −0.28) |
| Injury, poisoning, and procedural complications | 36 (3.8%) | 27 (2.6%) | 1.13 (−0.43 to 2.76) |
| Gastrointestinal disorders | 25 (2.6%) | 21 (2.1%) | 0.56 (−0.79 to 1.98) |
| Gastroesophageal reflux disease | 4 (0.4%) | 0 (0.0%) | 0.42 (0.04 to 1.07) |
| Musculoskeletal and connective tissue disorders | 18 (1.9%) | 11 (1.1%) | 0.81 (−0.27 to 1.99) |
| Osteoarthritis | 13 (1.4%) | 3 (0.3%) | 1.07 (0.31 to 2.05) |
| Respiratory, thoracic, and mediastinal disorders | 15 (1.6%) | 12 (1.2%) | 0.40 (−0.66 to 1.52) |
| Metabolism and nutrition disorders | 1 (0.1%) | 13 (1.3%) | −1.17 (−2.07 to −0.52) |
| Hyponatremia | 1 (0.1%) | 7 (0.7%) | −0.58 (−1.31 to −0.03) |
| Dehydration | 0 (0.0%) | 5 (0.5%) | −0.49 (−1.14 to −0.09) |
| System organ class preferred term patients with one or more: . | Age ≥75 years old . | ||
|---|---|---|---|
| Sitagliptin . | Placebo . | Difference . | |
| (n = 956) . | (n = 1,023) . | (95% CI) . | |
| Neoplasms benign, malignant, and unspecified (including cysts and polyps) | 80 (8.4%) | 94 (9.2%) | −0.82 (−3.33 to 1.70) |
| Basal cell carcinoma | 11 (1.2%) | 24 (2.3%) | −1.20 (−2.44 to −0.04) |
| Squamous cell carcinoma | 5 (0.5%) | 17 (1.7%) | −1.14 (−2.18 to −0.24) |
| Squamous cell carcinoma of skin | 3 (0.3%) | 14 (1.4%) | −1.05 (−2.01 to −0.28) |
| Injury, poisoning, and procedural complications | 36 (3.8%) | 27 (2.6%) | 1.13 (−0.43 to 2.76) |
| Gastrointestinal disorders | 25 (2.6%) | 21 (2.1%) | 0.56 (−0.79 to 1.98) |
| Gastroesophageal reflux disease | 4 (0.4%) | 0 (0.0%) | 0.42 (0.04 to 1.07) |
| Musculoskeletal and connective tissue disorders | 18 (1.9%) | 11 (1.1%) | 0.81 (−0.27 to 1.99) |
| Osteoarthritis | 13 (1.4%) | 3 (0.3%) | 1.07 (0.31 to 2.05) |
| Respiratory, thoracic, and mediastinal disorders | 15 (1.6%) | 12 (1.2%) | 0.40 (−0.66 to 1.52) |
| Metabolism and nutrition disorders | 1 (0.1%) | 13 (1.3%) | −1.17 (−2.07 to −0.52) |
| Hyponatremia | 1 (0.1%) | 7 (0.7%) | −0.58 (−1.31 to −0.03) |
| Dehydration | 0 (0.0%) | 5 (0.5%) | −0.49 (−1.14 to −0.09) |
Analysis cohort is all older patients as treated. This table includes 1) sytem organ classes exceeding 1% or where the 95% CI excludes 0; 2) within the system organ classes that exceed 1%, any preferred term that exceeds 1%; and 3) any individual preferred term where the 95% CI excludes 0.