Table 6 Adverse drug reactions of special interest
| STELLA-LONG TERM (safety analysis set n = 11,051) | Pre-approval clinical trials | ||||||
|---|---|---|---|---|---|---|---|
| Total number of patients experiencing an ADR | Serious | Non-serious | Total (n = 1669) | ||||
| All ADRs | 1616 | (14.6) | 107 | (0.97) | 1539 | (13.9) | (32.9) |
| ADRs of special interest | |||||||
| Polyuria/pollakiuria | 571 | (5.2) | 1 | (0.01) | 570 | (5.2) | (10.0) |
| Volume depletion-related events, including dehydration | 196 | (1.8) | 9 | (0.08) | 189 | (1.7) | (4.5) |
| Skin complications | 166 | (1.5) | 4 | (0.04) | 162 | (1.5) | (3.5) |
| Genital infection | 135 | (1.2) | 2 | (0.02) | 133 | (1.2) | (2.0) |
| Urinary tract infection | 115 | (1.0) | 5 | (0.05) | 110 | (1.0) | (1.8) |
| Renal disorder | 115 | (1.0) | 3 | (0.03) | 112 | (1.0) | (4.6) |
| Hepatic disorder | 82 | (0.74) | 6 | (0.05) | 78 | (0.71) | (1.0) |
| Hypoglycemia | 39 | (0.35) | 3 | (0.03) | 36 | (0.33) | (1.4) |
| Cardiovascular diseasea | 30 | (0.27) | 19 | (0.17) | 11 | (0.10) | (1.0) |
| Cerebrovascular diseaseb | 23 | (0.21) | 20 | (0.18) | 3 | (0.03) | (0.2) |
| Malignant tumor | 22 | (0.20) | 19 | (0.17) | 3 | (0.03) | (0.2) |
| Ketoacidosis, events related to ketone-body increase | 3 | (0.03) | 0 | (0.00) | 3 | (0.03) | (0.7) |
| Fracture | 2 | (0.02) | 1 | (0.01) | 1 | (0.01) | 0 |
Data are presented as number of events (%), unless otherwise indicated
ADR adverse drug reaction
aIncidence of cardiovascular disease was 4.4/1000 person-years [34] and 9.59/1000 person-years [35] in the JDDM and JDCS studies, respectively
bIncidence of cerebrovascular disease was 3.1/1000 person-years [34] and 7.45/1000 person-years [35] in the JDDM and JDCS studies, respectively