Table 2.
STEP 1 | STEP 2 | STEP 3* | |||||
---|---|---|---|---|---|---|---|
Semaglutide 2.4 mg (n = 1,306) | Placebo (n = 655) | Semaglutide 1.0 mg (n = 402) | Semaglutide 2.4 mg (n = 403) | Placebo (n = 402) | Semaglutide 2.4 mg (n = 407) | Placebo (n = 204) | |
Renal and urinary disorders | 3 (0.2) | 2 (0.3) | 2 (0.5) | 4 (1.0) | 2 (0.5) | 0 | 0 |
Acute kidney injury | 3 (0.2) | 1 (0.2) | 2 (0.5) | 3 (0.7) | 2 (0.5) | 0 | 0 |
Renal impairment | 1 (<0.1) | 1 (0.2) | 0 | 1 (0.2) | 0 | 0 | 0 |
Data are n (%) and are for the safety analysis set unless otherwise indicated. N is number of patients experiencing at least one event and % is percentage of patients experiencing at least one event. Adverse events with onset date during on-treatment period. A time point is considered as on-treatment if any dose of trial product has been administered within the prior 49 days. Sorted in descending order by System Organ Class and Preferred Term based, respectively, on the percentage of patients in the semaglutide 2.4 mg arm experiencing at least one event.
There were no events of acute renal failure identified by the Medical Dictionary for Regulatory Activities terminology search in either of the treatment groups.