Table 3 Description of adverse events-ITT.
From: Rhythm training improves word-reading in children with dyslexia
Mila-Learn N = 22 | Placebo N = 17 | Total N = 39 | |
|---|---|---|---|
Adverse event intensity | |||
Mild | 18 (81.8%) | 13 (76.5%) | 31 (79.5%) |
Moderate | 4 (18.2%) | 3 (17.6%) | 7 (17.9%) |
Severe | 0 | 1 (5.9%) | 1 (2.6%) |
Adverse event triggering event | |||
Intercurrent illness | 15 (68.2%) | 12 (70.6%) | 27 (69.2%) [54.7; 83.7] |
Due to protocol | 0 (0%) | 1 (5.9%) | 1 (2.6%) [0.0; 7.5] |
Not evaluable | 7 (31.8%) | 4 (23.5%) | 11 (28.2%) [14.1; 42.3] |
Adverse event severity | |||
No | 22 (100.0%) | 17 (100.0%) | 39 (100.0%) |
Expected adverse event | |||
No | 22 (100.0%) | 17 (100.0%) | 39 (100.0%) |
Relation between the adverse event and the serious game | |||
Related | 0 (0%) | 1 (5.9%) | 1 (2.6%) |
Unrelated | 22 (100.0%) | 15 (88.2%) | 37 (94.9%) |
Not evaluable | 0 (0%) | 1 (5.9%) | 1 (2.6%) |
