Table 4. Participants With Reportable Adverse Events During the Intervention Period by Treatment Group.
| Adverse Event | No. (%) | |
|---|---|---|
| Training Group (n = 105) | Active Control Group (n = 105) | |
| ≥1 Reportable adverse eventa | 17 (16.2) | 15 (14.3) |
| No. of reportable adverse events per participant | ||
| 1 | 13 (12.4) | 14 (13.3) |
| 2 | 3 (2.9) | 1 (1.0) |
| ≥3 | 1 (1.0) | 0 |
| Severityb | ||
| Mild or moderate | 11 (10.5) | 10 (9.5) |
| Severe or life-threatening | 5 (4.8) | 5 (4.8) |
| Fatal | 1 (1.0) | 0c |
| Relatednessd | ||
| Not related | 15 (14.3) | 11 (10.5) |
| Possibly related | 0 | 3 (2.9)e |
| Definitely related | 2 (1.9)f | 0 |
| Unknown | 0 | 1 (1.0) |
| Most frequent preferred terms describing eventsg | ||
| Fall | 6 (5.7) | 4 (3.8) |
| Femur/hip fracture | 2 (1.9) | 2 (1.9) |
| Pneumonia | 2 (1.9) | 0 |
| Urinary tract infection | 2 (1.9) | 0 |
| Dehydration | 0 | 2 (1.9) |
| Dyspnea | 0 | 2 (1.9) |
An adverse event was considered reportable if it occurred while the participant was under the supervision of study staff or if it resulted in (1) hospitalization (or prolongation of an existing hospitalization), (2) a life-threatening condition, (3) death, (4) permanent or significant disability or incapacity, or (5) medical or surgical intervention. The intervention period was defined as the first 16 weeks after randomization or the last intervention visit, whichever was later.
Participants who had multiple reportable adverse events of different severity were classified according to the most severe reportable adverse event.
Two active control participants died but are not included in this Table because they died after the intervention period. Neither death was deemed to be related to the intervention.
Participants who had multiple reportable adverse events of different relatedness were classified according to the most significant relatedness status, with “unknown” being considered the least significant, “not related” being considered more significant, “possibly related” being next most significant, and “definitely related” being the most significant.
Of the 3 participants whose reportable adverse event was judged to be possibly related to being in the study, 1 fell backward in a parking lot and suffered a head wound, 1 fell and was hospitalized for a femur fracture, and 1 experienced a transient alteration of awareness during an intervention visit.
Of the 2 participants whose reportable adverse event was judged to be definitely related to being in the study, 1 fell during an intervention visit and was hospitalized for a femur fracture and 1 fell without injury during an intervention visit.
The percentage is the number of participants with at least 1 reportable adverse event described by the preferred term divided by the number of randomized participants. If a participant had more than 1 reportable adverse event with the same preferred term, the participant was only counted once. Because some reportable adverse events were described by multiple preferred terms, the total number of preferred terms is greater than the total number of reportable adverse events.