Table 3 Unanticipated adverse events at 10 weeks
Event category | Active tDCS (n = 87) | Sham tDCS (n = 86) | Difference (95% CI) | P |
|---|---|---|---|---|
Ear and labyrinth disorders | 2 (2.3) | 2 (2.3) | 0 (−6.2 to 6.0) | 0.99 |
Eye disorders | 3 (3.4) | 1 (1.2) | 2.3 (−3.3 to 8.9) | 0.62 |
Gastrointestinal disorders | 2 (2.3) | 1 (1.2) | 1.1 (−4.5 to 7.0) | 0.99 |
General disorders and administration site conditions | 3 (3.4) | 2 (2.3) | 1.1 (−5.2 to 8.0) | 0.99 |
Infections and infestations | 1 (1.1) | 1 (1.2) | 0 (−5.5 to 5.3) | 0.99 |
Injury, poisoning and procedural complications | 2 (2.3) | 0 (0) | 2.3 (−2.2 to 8.1) | 0.49 |
Nervous system disorders | 7 (8.0) | 8 (9.3) | −1.3 (−10.4 to 8.0) | 0.79 |
Psychiatric disorders | 4 (4.6) | 4 (4.7) | −0.1 (−7.5 to 7.3) | 0.99 |
Skin and subcutaneous tissue disorders | 17 (19.5) | 7 (8.1) | 11.4 (1.0 to 22.3) | 0.05 |
Vascular disorders | 1 (1.1) | 0 (0) | 1.1 (−3.3 to 6.4) | 0.99 |
Number of participants with adverse events at week 10 | ||||
≥1 Mild adverse event | 21 (24.1) | 14 (16.3) | 7.9 (−4.5 to 20.3) | 0.25 |
≥1 Moderate adverse event | 13 (14.9) | 18 (9.3) | 5.6 (−4.5 to 16.1) | 0.35 |
≥1 Severe adverse event | 3 (3.4) | 1 (1.2) | 2.3 (−3.3 to 8.9) | 0.62 |
Serious adverse events during the trial | ||||
Hospitalization for hypertension | 1 (1.1) | 0 (0) | 1.1 (–3.3 to 6.4) | 0.99 |
Death | 0 | 0 | – | – |
New-onset mania or hypomania | 0 | 0 | – | – |
