Table 4.
Summary of overall safety and pre-specified adverse events (AEs)
| Number of patients, n (%) | Placebo (n = 97) |
E5/S100 (n = 98) |
E15/S100 (n = 96) |
|---|---|---|---|
| Overall safety | |||
| One or more AEs (ER) | 41 (42.3) | 44 (44.9) | 43 (44.8) |
| AEs related to study drug (ER)a | 8 (8.2) | 9 (9.2) | 13 (13.5) |
| One or more SAEs (IR) | 5 (5.2) | 2 (2.0) | 3 (3.1) |
| Serious AEs related to study drug (IR) | 0 (0) | 0 (0) | 0 (0) |
| Deaths (IR) | 0 (0) | 0 (0) | 0 (0) |
| AEs leading to discontinuation (IR) | 3 (3.1) | 2 (2.0) | 2 (2.1) |
| Pre-specified AEs (ER)b | |||
| Genital mycotic infection (men) | 0 (0.0) | 3 (5.3) | 1 (1.9) |
| Genital mycotic infection (women) | 2 (5.0) | 2 (4.9) | 3 (7.0) |
| Urinary tract infection | 5 (5.2) | 8 (8.2) | 3 (3.1) |
| Symptomatic hypoglycemiac | 1 (1.0) | 3 (3.1) | 3 (3.1) |
| Hypovolemia | 1 (1.0) | 2 (2.0) | 2 (2.1) |
AE adverse event, E ertugliflozin, ER analysis excludes events occurring after the initiation of rescue medication, IR analysis includes events occurring after the initiation of rescue medication, S sitagliptin, SAE serious adverse event
aAEs reported by the investigator
bPre-specified AEs were specified for inferential testing without multiplicity control; no P values for comparisons to placebo were < 0.05
cEvent with clinical symptoms reported by the investigator as hypoglycemia (concurrent finger stick glucose not required)