Table 3.
Characteristics of (serious) adverse events (after follow-up interview)
|
Pre-assessment N = 823 |
After session 1 N = 649 |
After session 3 N = 556 |
After session 5 N = 537 |
Follow-up assessment N = 533 |
||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Lecture | PLH | Lecture | PLH | Lecture | PLH | Lecture | PLH | Lecture | PLH | |
| Total N | 408 | 415 | 285 | 364 | 255 | 301 | 229 | 308 | 247 | 286 |
| AE data available | 401 | 411 | 284 | 364 | 253 | 301 | 229 | 308 | 244 | 283 |
| Follow-up call required | 42 (10%)a | 45 (11%) | 32 (12%)a | 35 (10%) | 17 (7%)a | 24 (8%) | 7 (3%)a | 15 (5%) | 28 (12%) | 27 (10%) |
| Results of follow-up interview | ||||||||||
| No AE | 3 (< 1%) | 1 (< 1%) | 1 (< 1%) | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| AE | 35 (9%) | 42 (10%) | 30 (11%) | 35 (10%) | 16 (5%) | 24 (8%) | 6 (3%) | 15 (5%) | 27 (11%) | 23 (8%) |
| SAE | 3 (< 1%) | 2 (< 1%) | 0 | 0 | 0 | 0 | 0 | 0 | 1 (< 1%) | 4 (1%) |
| Happened to | ||||||||||
| Caregiver | 31 (8%) | 35 (9%) | 14 (5%) | 22 (6%) | 4 (2%) | 14 (4%) | 4 (2%) | 8 (3%) | 14 (6%) | 14 (5%) |
| Child | 10 (2%) | 10 (2%) | 16 (6%) | 13 (4%) | 12 (5%) | 9 (3%) | 2 (1%) | 7 (2%) | 13 (5%) | 11 (4%) |
| Expected | 21 (5%) | 21 (5%) | 13 (5%) | 11 (3%) | 4 (2%) | 7 (2%) | 4 (2%) | 5 (2%) | 9 (4%) | 8 (3%) |
| Definitely/probably/possibly related to study | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Unrelated to studyb | 38 (100%) | 44 (100%) | 30 (100%) | 35 (100%) | 16 (100%) | 24 (100%) | 6 (100%) | 15 (100%) | 28 (100%) | 27 (100%) |
| COVID-19 related | 7 (2%) | 3 (1%) | 4 (2%) | 9 (3%) | 1 (< 1%) | 4 (1%) | 0 | 2 (1%) | 5 (19%) | 4 (17%) |
| N of cases with more than one AE | ||||||||||
| 2 AE | 8 (2%) | 13 (3%) | 2 (1%) | 5 (1%) | 3 (1%) | 4 (1%) | 0 | 3 (1%) | 6 (3%) | 6 (3%) |
| 3 AE | 4 (1%) | 7 (2%) | 1 (< 1%) | 2 (1%) | 3 (1%) | 2 (1%) | 0 | 0 | 2 (1%) | 1 (< 1%) |
Note. Displayed is the number of families that reported at least one AE per assessment point in both conditions. Percentages relate to the cases per randomised group with available AE data at each assessment point
an = 1 case with required follow-up call according to checklist data, but follow-up call form is missing
bPercentages relate to the cases with at least one (S)AE per randomised group at each assessment point