Table 2.
Adverse drug reactions in the safety analysis population (first age category analysis) of STELLA-LONG TERM, in pre-approval clinical trials, and STELLA-ELDER
| ADRs, n (%) | Pre-approval (n = 1669) [2–7] | STELLA-LONG TERM | STELLA-ELDER (n = 8505) [9] | |||
|---|---|---|---|---|---|---|
| All (n = 11,051) | < 65 years (n = 7894) | ≥ 65 years (n = 3157) | P-valuea | |||
| Any ADR | 549 (32.89) | 2129 (19.27) | 1528 (19.36) | 601 (19.04) | 0.701 | 1438 (16.9) |
| Serious ADR | 14 (0.8) | 210 (1.90) | 122 (1.55) | 88 (2.79) | < 0.001 | 127 (1.5) |
| ADRs of special interest | ||||||
| Polyuria/pollakiuria | 163 (10.0) | 612 (5.54) | 471 (5.97) | 141 (4.47) | 0.002 | 170 (2.0) |
| Volume depletion | 73 (4.5) | 243 (2.20) | 167 (2.12) | 76 (2.41) | 0.345 | 266 (3.1) |
| Skin complications | 59 (3.5) | 198 (1.79) | 128 (1.62) | 70 (2.22) | 0.033 | 269 (3.2) |
| Renal disorder | 76 (4.6) | 191 (1.73) | 119 (1.51) | 72 (2.28) | 0.005 | 118 (1.4) |
| Urinary tract infection | 29 (1.8) | 170 (1.54) | 115 (1.46) | 55 (1.74) | 0.271 | 118 (1.4) |
| Genital infection | 32 (2.0) | 161 (1.46) | 126 (1.60) | 35 (1.11) | 0.053 | 166 (2.0) |
| Hepatic disorder | 17 (1.0) | 133 (1.20) | 110 (1.39) | 23 (0.73) | 0.004 | 19 (0.2) |
| Cardiovascular disease | 16 (1.0) | 67 (0.61) | 50 (0.63) | 17 (0.54) | 0.562 | 24 (0.3) |
| Hypoglycemia | 22 (1.4) | 57 (0.52) | 34 (0.43) | 23 (0.73) | 0.048 | 58 (0.7) |
| Malignant tumor | 4 (0.2) | 51 (0.46) | 19 (0.24) | 32 (1.01) | < 0.001 | 11 (0.1) |
| Cerebrovascular disease | 4 (0.2) | 48 (0.43) | 29 (0.37) | 19 (0.60) | 0.090 | 36 (0.4) |
| Ketone body related events | 11 (0.7) | 7 (0.06) | 6 (0.08) | 1 (0.03) | –b | 2 (0.02) |
| Fracture | 0 | 4 (0.04) | 4 (0.05) | 0 | –b | 2 (0.02) |
| Lower limb amputation | 0 | 0 | 0 | 0 | –b | 0 |
No. of patients (%) are shown
ADR adverse drug reaction
aChi-squared test for difference between BMI subgroups
bNo P value was calculated when at least one element of the contingency table was < 10