Table 3.
Adverse events among all randomized subjects
| Characteristics | UC (n = 156 [%]) | BI (n = 149 [%]) | P Value* | ||
|---|---|---|---|---|---|
| Adverse events | 95 | (48.97) | 99 | (51.03) | |
| Total adverse events | |||||
| Subjects with ≥1 AE | 65 | (41.67) | 60 | (40.27) | 0.80 |
| Subjects with no AEs | 91 | (58.33) | 89 | (59.73) | |
| Postrandomization adverse events | |||||
| Subjects with ≥1 AE | 59 | (37.82) | 53 | (35.57) | 0.94 |
| Subjects with no AEs | 97 | (62.18) | 96 | (64.43) | |
| Prerandomization adverse events | |||||
| Subjects with ≥1 AE | 6 | (3.85) | 7 | (4.69) | 0.71 |
| Subjects with no AEs | 150 | (96.15) | 142 | (95.31) | |
| Adverse event categories | |||||
| Death | 4 | (4.21) | 4 | (4.04) | |
| Hospitalization–cardiac | 10 | (10.53) | 13 | (13.13) | |
| Hospitalization–exacerbation | 47 | (49.47) | 28 | (28.28) | |
| Hospitalization–other | 11 | (11.58) | 21 | (21.21) | |
| Injury/fall | 9 | (9.47) | 12 | (12.12) | |
| Surgery† | 14 | (14.74) | 21 | (21.21) | |
| Subjects with SAEs | 72 | (75.79) | 66 | (66.66) | 0.20 |
Definition of abbreviations: AE = adverse event; BI = behavioral intervention; SAE = serious adverse event; UC = usual care.
*
P values correspond to χ2 test.
†
Surgeries were non–COPD related.