Table 2.
Adverse and special interest events up to week 102
| Placebo + metformin | Dapagliflozin 2.5 mg + metformin |
Dapagliflozin 5 mg + metformin |
Dapagliflozin 10 mg + metformin | |
| N | 137 | 137 | 137 | 135 |
| At least one adverse event | 111 (81.0) | 111 (81.0) | 111 (81.0) | 111 (82.2) |
| At least one related adverse event | 28 (20.4) | 36 (26.3) | 33 (24.1) | 45 (33.3) |
| Adverse event leading to discontinuation | 9 (6.6) | 7 (5.1) | 5 (3.6) | 6 (4.4) |
| At least one serious adverse event | 14 (10.2) | 15 (10.9) | 9 (6.6) | 14 (10.4) |
| Deaths | 1 (0.7) | 2 (1.5) | 0 | 0 |
| Most common adverse events (>10% in any treatment group): | ||||
| Back pain | 11 (8.0) | 11 (8.0) | 7 (5.1) | 18 (13.3) |
| Influenza | 15 (10.9) | 19 (13.9) | 20 (14.6) | 17 (12.6) |
| Diarrhea | 10 (7.3) | 7 (5.1) | 9 (6.6) | 16 (11.9) |
| Urinary tract infection | 8 (5.8) | 6 (4.4) | 8 (5.8) | 16 (11.9) |
| Headache | 8 (5.8) | 10 (7.3) | 13 (9.5) | 15 (11.1) |
| Nasopharyngitis | 12 (8.8) | 16 (11.7) | 8 (5.8) | 12 (8.9) |
| Upper respiratory tract infection | 14 (10.2) | 9 (6.6) | 5 (3.7) | 5 (3.7) |
| Adverse events of special interest: | ||||
| Suggestive of urinary tract infection | 11 (8.0) | 11 (8.0) | 12 (8.8) | 18 (13.3) |
| Experiencing a single event | 8/11 (72.7) | 8/11 (72.7) | 10/12 (83.3) | 11/18 (61.1) |
| Men | 3/76 (3.9) | 2/70 (2.9) | 2/69 (2.9) | 4/77 (5.2) |
| Women | 8/61 (13.1) | 9/67 (13.4) | 10/68 (14.7) | 14/58 (24.1) |
| Suggestive of genital infection | 7 (5.1) | 16 (11.7) | 20 (14.6) | 17 (12.6) |
| Experiencing a single event | 7/7 (100) | 15/16 (93.8) | 16/20 (80.0) | 14/17 (82.4) |
| Men | 0/76 | 4/70 (5.7) | 4/69 (5.8) | 5/77 (6.5) |
| Women | 7/61 (11.5) | 12/67 (17.9) | 16/68 (23.5) | 12/58 (20.7) |
| Renal impairment or failure | 2 (1.5) | 6 (4.4) | 4 (2.9) | 2 (1.5) |
| Hypoglycemia: | ||||
| Total patients with hypoglycemia | 8 (5.8) | 5 (3.6) | 7 (5.1) | 7 (5.2) |
| Major episode of hypoglycemiaa | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
| Hypotension, dehydration, hypovolemia | 2 (1.5) | 0 (0) | 3 (2.2) | 2 (1.5) |
Data are n (%) or n out of N (%); includes data after rescue. aMajor episode defined as a symptomatic episode requiring external assistance due to severe impairment in consciousness or behavior with a capillary or plasma glucose value <3 mmol/l and prompt recovery after glucose or glucagon administration.