Safety outcomes in follow-up by treatment assignment according to background diuretic therapy
| Safety outcome . | No diuretic (n = 683) . | Non-loop diuretic (n = 769) . | <40 mga (n = 1811) . | 40 mga (n = 1902) . | >40 mga (n = 1098) . | Pinteraction (diuretic use/type) . | Pinteraction (diuretic dose) . | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| . | Placebo . | Dapagliflozin . | Placebo . | Dapagliflozin . | Placebo . | Dapagliflozin . | Placebo . | Dapagliflozin . | Placebo . | Dapagliflozin . | . | . |
| Any SAE | 143 (41.6%) | 126 (37.4%) | 135 (35.8%) | 140 (36.0%) | 380 (42.3%) | 367 (40.3%) | 457 (47.6%) | 423 (45.1%) | 308 (56.4%) | 305 (55.4%) | 0.84 | 0.51 |
| Any AE leading to discontinuation of IP | 15 (4.4%) | 19 (5.6%) | 11 (2.9%) | 23 (5.9%) | 57 (6.3%) | 57 (6.3%) | 54 (5.6%) | 41 (4.4%) | 44 (8.1%) | 42 (7.6%) | 0.65 | 0.43 |
| Any AE leading to interruption of IP | 50 (14.5%) | 38 (11.3%) | 54 (14.3%) | 48 (12.3%) | 131 (14.6%) | 122 (13.4%) | 148 (15.4%) | 125 (13.3%) | 111 (20.3%) | 103 (18.7%) | 0.96 | 0.50 |
| Any AE that potentially placed a patient at increased risk for a lower limb amputationb | 14 (4.1%) | 11 (3.3%) | 11 (2.9%) | 8 (2.1%) | 48 (5.3%) | 46 (5.0%) | 57 (5.9%) | 60 (6.4%) | 69 (12.6%) | 63 (11.4%) | 0.90 | 0.80 |
| Any SAE or DAE suggestive of volume depletion | 3 (0.9%) | 1 (0.3%) | 1 (0.3%) | 2 (0.5%) | 11 (1.2%) | 13 (1.4%) | 10 (1.0%) | 11 (1.2%) | 7 (1.3%) | 15 (2.7%) | 0.50 | 0.14 |
| Any renal SAE or DAE | 6 (1.7%) | 5 (1.5%) | 4 (1.1%) | 6 (1.5%) | 18 (2.0%) | 15 (1.6%) | 18 (1.9%) | 20 (2.1%) | 33 (6.0%) | 27 (4.9%) | 0.76 | 0.93 |
| Safety outcome . | No diuretic (n = 683) . | Non-loop diuretic (n = 769) . | <40 mga (n = 1811) . | 40 mga (n = 1902) . | >40 mga (n = 1098) . | Pinteraction (diuretic use/type) . | Pinteraction (diuretic dose) . | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| . | Placebo . | Dapagliflozin . | Placebo . | Dapagliflozin . | Placebo . | Dapagliflozin . | Placebo . | Dapagliflozin . | Placebo . | Dapagliflozin . | . | . |
| Any SAE | 143 (41.6%) | 126 (37.4%) | 135 (35.8%) | 140 (36.0%) | 380 (42.3%) | 367 (40.3%) | 457 (47.6%) | 423 (45.1%) | 308 (56.4%) | 305 (55.4%) | 0.84 | 0.51 |
| Any AE leading to discontinuation of IP | 15 (4.4%) | 19 (5.6%) | 11 (2.9%) | 23 (5.9%) | 57 (6.3%) | 57 (6.3%) | 54 (5.6%) | 41 (4.4%) | 44 (8.1%) | 42 (7.6%) | 0.65 | 0.43 |
| Any AE leading to interruption of IP | 50 (14.5%) | 38 (11.3%) | 54 (14.3%) | 48 (12.3%) | 131 (14.6%) | 122 (13.4%) | 148 (15.4%) | 125 (13.3%) | 111 (20.3%) | 103 (18.7%) | 0.96 | 0.50 |
| Any AE that potentially placed a patient at increased risk for a lower limb amputationb | 14 (4.1%) | 11 (3.3%) | 11 (2.9%) | 8 (2.1%) | 48 (5.3%) | 46 (5.0%) | 57 (5.9%) | 60 (6.4%) | 69 (12.6%) | 63 (11.4%) | 0.90 | 0.80 |
| Any SAE or DAE suggestive of volume depletion | 3 (0.9%) | 1 (0.3%) | 1 (0.3%) | 2 (0.5%) | 11 (1.2%) | 13 (1.4%) | 10 (1.0%) | 11 (1.2%) | 7 (1.3%) | 15 (2.7%) | 0.50 | 0.14 |
| Any renal SAE or DAE | 6 (1.7%) | 5 (1.5%) | 4 (1.1%) | 6 (1.5%) | 18 (2.0%) | 15 (1.6%) | 18 (1.9%) | 20 (2.1%) | 33 (6.0%) | 27 (4.9%) | 0.76 | 0.93 |
Dose in furosemide equivalents.
Preceeding events were identified based on a predefined list of the European Medicines Agency’s Pharmacovigilance Risk Assessment Committee preferred terms.
SAE, serious adverse event; AE, adverse event; IP, investigational product; DAE, adverse events leading to discontinuations.
Safety outcomes in follow-up by treatment assignment according to background diuretic therapy
| Safety outcome . | No diuretic (n = 683) . | Non-loop diuretic (n = 769) . | <40 mga (n = 1811) . | 40 mga (n = 1902) . | >40 mga (n = 1098) . | Pinteraction (diuretic use/type) . | Pinteraction (diuretic dose) . | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| . | Placebo . | Dapagliflozin . | Placebo . | Dapagliflozin . | Placebo . | Dapagliflozin . | Placebo . | Dapagliflozin . | Placebo . | Dapagliflozin . | . | . |
| Any SAE | 143 (41.6%) | 126 (37.4%) | 135 (35.8%) | 140 (36.0%) | 380 (42.3%) | 367 (40.3%) | 457 (47.6%) | 423 (45.1%) | 308 (56.4%) | 305 (55.4%) | 0.84 | 0.51 |
| Any AE leading to discontinuation of IP | 15 (4.4%) | 19 (5.6%) | 11 (2.9%) | 23 (5.9%) | 57 (6.3%) | 57 (6.3%) | 54 (5.6%) | 41 (4.4%) | 44 (8.1%) | 42 (7.6%) | 0.65 | 0.43 |
| Any AE leading to interruption of IP | 50 (14.5%) | 38 (11.3%) | 54 (14.3%) | 48 (12.3%) | 131 (14.6%) | 122 (13.4%) | 148 (15.4%) | 125 (13.3%) | 111 (20.3%) | 103 (18.7%) | 0.96 | 0.50 |
| Any AE that potentially placed a patient at increased risk for a lower limb amputationb | 14 (4.1%) | 11 (3.3%) | 11 (2.9%) | 8 (2.1%) | 48 (5.3%) | 46 (5.0%) | 57 (5.9%) | 60 (6.4%) | 69 (12.6%) | 63 (11.4%) | 0.90 | 0.80 |
| Any SAE or DAE suggestive of volume depletion | 3 (0.9%) | 1 (0.3%) | 1 (0.3%) | 2 (0.5%) | 11 (1.2%) | 13 (1.4%) | 10 (1.0%) | 11 (1.2%) | 7 (1.3%) | 15 (2.7%) | 0.50 | 0.14 |
| Any renal SAE or DAE | 6 (1.7%) | 5 (1.5%) | 4 (1.1%) | 6 (1.5%) | 18 (2.0%) | 15 (1.6%) | 18 (1.9%) | 20 (2.1%) | 33 (6.0%) | 27 (4.9%) | 0.76 | 0.93 |
| Safety outcome . | No diuretic (n = 683) . | Non-loop diuretic (n = 769) . | <40 mga (n = 1811) . | 40 mga (n = 1902) . | >40 mga (n = 1098) . | Pinteraction (diuretic use/type) . | Pinteraction (diuretic dose) . | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| . | Placebo . | Dapagliflozin . | Placebo . | Dapagliflozin . | Placebo . | Dapagliflozin . | Placebo . | Dapagliflozin . | Placebo . | Dapagliflozin . | . | . |
| Any SAE | 143 (41.6%) | 126 (37.4%) | 135 (35.8%) | 140 (36.0%) | 380 (42.3%) | 367 (40.3%) | 457 (47.6%) | 423 (45.1%) | 308 (56.4%) | 305 (55.4%) | 0.84 | 0.51 |
| Any AE leading to discontinuation of IP | 15 (4.4%) | 19 (5.6%) | 11 (2.9%) | 23 (5.9%) | 57 (6.3%) | 57 (6.3%) | 54 (5.6%) | 41 (4.4%) | 44 (8.1%) | 42 (7.6%) | 0.65 | 0.43 |
| Any AE leading to interruption of IP | 50 (14.5%) | 38 (11.3%) | 54 (14.3%) | 48 (12.3%) | 131 (14.6%) | 122 (13.4%) | 148 (15.4%) | 125 (13.3%) | 111 (20.3%) | 103 (18.7%) | 0.96 | 0.50 |
| Any AE that potentially placed a patient at increased risk for a lower limb amputationb | 14 (4.1%) | 11 (3.3%) | 11 (2.9%) | 8 (2.1%) | 48 (5.3%) | 46 (5.0%) | 57 (5.9%) | 60 (6.4%) | 69 (12.6%) | 63 (11.4%) | 0.90 | 0.80 |
| Any SAE or DAE suggestive of volume depletion | 3 (0.9%) | 1 (0.3%) | 1 (0.3%) | 2 (0.5%) | 11 (1.2%) | 13 (1.4%) | 10 (1.0%) | 11 (1.2%) | 7 (1.3%) | 15 (2.7%) | 0.50 | 0.14 |
| Any renal SAE or DAE | 6 (1.7%) | 5 (1.5%) | 4 (1.1%) | 6 (1.5%) | 18 (2.0%) | 15 (1.6%) | 18 (1.9%) | 20 (2.1%) | 33 (6.0%) | 27 (4.9%) | 0.76 | 0.93 |
Dose in furosemide equivalents.
Preceeding events were identified based on a predefined list of the European Medicines Agency’s Pharmacovigilance Risk Assessment Committee preferred terms.
SAE, serious adverse event; AE, adverse event; IP, investigational product; DAE, adverse events leading to discontinuations.
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