Table 3. Serious Adverse Events by randomised group.
| Serious Adverse Events | Intervention | Usual care | Total |
|---|---|---|---|
| (n = 493) | (n = 517) | (n = 1010) | |
| Total number of SAEs | 53 | 42 | 95 |
| Number of participants with one or more SAEs | 49 | 37 | 86 |
| Number of events per participant, n (%) | |||
| 1 | 45 (91.8) | 33 (89.2) | 78 (90.7) |
| 2 | 4 (8.2) | 3 (8.1) | 7 (8.1) |
| 3 | 0 (0.0) | 1 (2.7) | 1 (1.2) |
| Event details, n (%) | |||
| Death | 8 (15.1) | 15 (35.7) | 23 (24.2) |
| Hospital required/prolonged | |||
| Life/limb threatening | 36 (67.9) | 26 (61.9) | 62 (65.3) |
| Disability | 2 (3.8) | 0 (0.0) | 2 (2.1) |
| Other | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| 7 (13.2) | 1 (2.4) | 8 (8.4) | |
| Intensity, n (%) | |||
| Mild | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Moderate | 5 (9.4) | 2 (4.8) | 7 (7.4) |
| Severe | 47 (88.7) | 40 (95.2) | 87 (91.6) |
| Missing* | 1 (1.9) | 0 (0.0) | 1 (1.1) |
| Outcome, n (%) | |||
| Recovered fully | 22 (41.5) | 12 (28.6) | 34 (35.8) |
| Recovered partially | 6 (11.3) | 2 (4.8) | 8 (8.4) |
| On-going | 16 (30.2) | 13 (31.0) | 29 (30.5) |
| Died | 8 (15.1) | 15 (35.7) | 23 (24.2) |
| Missing | 1 (1.9) | 0 (0.0) | 1 (1.1) |
| Relationship to any of the research procedures, n (%) | |||
| Unrelated | 35 (66.0) | 31 (73.8) | 66 (69.5) |
| Unlikely | 8 (15.1) | 6 (14.3) | 14 (14.7) |
| Possibly | 3 (5.7) | 0 (0.0) | 3 (3.2) |
| Probably | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Definitely | 2 (3.8) | 0 (0.0) | 2 (2.1) |
| Not able to assess | 4 (7.6) | 5 (11.9) | 9 (9.5) |
| Missing | 1 (1.9) | 0 (0.0) | 1 (1.1) |
| Expectedness, n (%) | |||
| Expected | 48 (90.6) | 37 (88.1) | 85 (89.5) |
| Unexpected | 4 (7.6) | 5 (11.9) | 9 (9.5) |
| Missing | 1 (1.9) | 0 (0.0) | 1 (1.1) |
*Event with missing outcome, relationship and expectedness was initially reported on participant’s 12 month questionnaire and followed up by a member of the research team. Participant reported breaking their leg and developing tendinopathy following a falls 8 months earlier. Event was not reported at the time and limited information was available when this event was followed up.