Summary of AEs
| . | Placebo (n = 188) . | Empagliflozin . | |
|---|---|---|---|
| 10 mg (n = 186) . | 25 mg (n = 189) . | ||
| One or more AEs | 169 (89.9) | 160 (86.0) | 160 (84.7) |
| One or more drug-related* AEs | 64 (34.0) | 56 (30.1) | 76 (40.2) |
| AEs leading to discontinuation | 9 (4.8) | 10 (5.4) | 9 (4.8) |
| One or more serious AEs | 22 (11.7) | 20 (10.8) | 22 (11.6) |
| Deaths | 0 (0) | 0 (0) | 1 (0.5) |
| AEs with frequency ≥5% in any group (by preferred term) | |||
| Hypoglycemia | 111 (59.0) | 97 (52.2) | 110 (58.2) |
| Nasopharyngitis | 40 (21.3) | 34 (18.3) | 27 (14.3) |
| Urinary tract infection | 23 (12.2) | 24 (12.9) | 24 (12.7) |
| Diarrhea | 17 (9.0) | 12 (6.5) | 18 (9.5) |
| Back pain | 14 (7.4) | 12 (6.5) | 15 (7.9) |
| Arthralgia | 10 (5.3) | 18 (9.7) | 11 (5.8) |
| Influenza | 12 (6.4) | 7 (3.8) | 14 (7.4) |
| Bronchitis | 12 (6.4) | 10 (5.4) | 8 (4.2) |
| Headache | 9 (4.8) | 8 (4.3) | 11 (5.8) |
| Hyperglycemia | 14 (7.4) | 6 (3.2) | 8 (4.2) |
| Hypertension | 10 (5.3) | 9 (4.8) | 7 (3.7) |
| Dizziness | 2 (1.1) | 5 (2.7) | 13 (6.9) |
| Gastroenteritis | 10 (5.3) | 8 (4.3) | 1 (0.5) |
| Special interest categories | |||
| Confirmed hypoglycemic AEs† | 109 (58.0) | 95 (51.1) | 109 (57.7) |
| Severe hypoglycemic AEs‡ | 3 (1.6) | 3 (1.6) | 1 (0.5) |
| Events consistent with urinary tract infection§ | 29 (15.4) | 29 (15.6) | 29 (15.3) |
| Male | 0 (0) | 5 (5.2) | 3 (3.6) |
| Female | 29 (25.7) | 24 (27.0) | 26 (24.8) |
| Acute pyelonephritis or urosepsis | 0 (0) | 0 (0) | 0 (0) |
| Events consistent with genital infectionΠ | 3 (1.6) | 8 (4.3) | 18 (9.5) |
| Male | 1 (1.3) | 1 (1.0) | 7 (8.3) |
| Female | 2 (1.8) | 7 (7.9) | 11 (10.5) |
| . | Placebo (n = 188) . | Empagliflozin . | |
|---|---|---|---|
| 10 mg (n = 186) . | 25 mg (n = 189) . | ||
| One or more AEs | 169 (89.9) | 160 (86.0) | 160 (84.7) |
| One or more drug-related* AEs | 64 (34.0) | 56 (30.1) | 76 (40.2) |
| AEs leading to discontinuation | 9 (4.8) | 10 (5.4) | 9 (4.8) |
| One or more serious AEs | 22 (11.7) | 20 (10.8) | 22 (11.6) |
| Deaths | 0 (0) | 0 (0) | 1 (0.5) |
| AEs with frequency ≥5% in any group (by preferred term) | |||
| Hypoglycemia | 111 (59.0) | 97 (52.2) | 110 (58.2) |
| Nasopharyngitis | 40 (21.3) | 34 (18.3) | 27 (14.3) |
| Urinary tract infection | 23 (12.2) | 24 (12.9) | 24 (12.7) |
| Diarrhea | 17 (9.0) | 12 (6.5) | 18 (9.5) |
| Back pain | 14 (7.4) | 12 (6.5) | 15 (7.9) |
| Arthralgia | 10 (5.3) | 18 (9.7) | 11 (5.8) |
| Influenza | 12 (6.4) | 7 (3.8) | 14 (7.4) |
| Bronchitis | 12 (6.4) | 10 (5.4) | 8 (4.2) |
| Headache | 9 (4.8) | 8 (4.3) | 11 (5.8) |
| Hyperglycemia | 14 (7.4) | 6 (3.2) | 8 (4.2) |
| Hypertension | 10 (5.3) | 9 (4.8) | 7 (3.7) |
| Dizziness | 2 (1.1) | 5 (2.7) | 13 (6.9) |
| Gastroenteritis | 10 (5.3) | 8 (4.3) | 1 (0.5) |
| Special interest categories | |||
| Confirmed hypoglycemic AEs† | 109 (58.0) | 95 (51.1) | 109 (57.7) |
| Severe hypoglycemic AEs‡ | 3 (1.6) | 3 (1.6) | 1 (0.5) |
| Events consistent with urinary tract infection§ | 29 (15.4) | 29 (15.6) | 29 (15.3) |
| Male | 0 (0) | 5 (5.2) | 3 (3.6) |
| Female | 29 (25.7) | 24 (27.0) | 26 (24.8) |
| Acute pyelonephritis or urosepsis | 0 (0) | 0 (0) | 0 (0) |
| Events consistent with genital infectionΠ | 3 (1.6) | 8 (4.3) | 18 (9.5) |
| Male | 1 (1.3) | 1 (1.0) | 7 (8.3) |
| Female | 2 (1.8) | 7 (7.9) | 11 (10.5) |
Data are n (%) for patients treated with ≥1 dose of trial medication.
*As assessed by the investigator.
†AEs consistent with hypoglycemia and with plasma glucose ≤70 mg/dL and/or requiring assistance.
‡AEs consistent with hypoglycemia and with plasma glucose ≤70 mg/dL and requiring assistance.
§Reports of urinary tract infection were based on 70 preferred terms.
ΠReports of genital infection were based on 89 preferred terms.