Table 3.
Adverse drug reactions by BMI and age in the safety analysis population
| Elderly patients, by BMI category | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| ≥ 65 years (n = 1944) | 65 to < 75 years (n = 1536) | ≥ 75 years (n = 408) | |||||||
| BMI | P valuea | BMI | P valuea | BMI | P valuea | ||||
| < 25 kg/m2 (n = 690) | ≥ 25 kg/m2 (n = 1254) | < 25 kg/m2 (n = 515) | ≥ 25 kg/m2 (n = 1021) | < 25 kg/m2 (n = 175) | ≥ 25 kg/m2 (n = 233) | ||||
| Any ADR | 122 (17.68) | 306 (24.40) | < 0.001 | 102 (19.81) | 258 (25.27) | 0.017 | 20 (11.43) | 48 (20.60) | 0.014 |
| Serious ADR | 19 (2.75) | 47 (3.75) | 0.247 | 15 (2.91) | 39 (3.82) | 0.362 | 4 (2.29) | 8 (3.43) | –b |
| Patients with a BMI < 25 kg/m2, by age | ||||||
|---|---|---|---|---|---|---|
| < 65 years (n = 883) | ≥ 65 years (n = 690) | P valuea | 65 to < 75 years (n = 515) | ≥ 75 years (n = 175) | P valuea | |
| ADR | 159 (18.01) | 122 (17.68) | 0.867 | 102 (19.81) | 20 (11.43) | 0.043 |
| Serious ADR | 12 (1.36) | 19 (2.75) | 0.048 | 15 (2.91) | 4 (2.29) | –b |
No. of patients (%) are shown
ADR adverse drug reaction, BMI body mass index
aChi-squared test for difference between BMI subgroups
bNo P value was calculated when at least one element of the contingency table was < 10