New harms and the response to those harms
| Harms—yes* n=39 | n (% of harms) | Severity median (range) | Clinical responses | Other | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Benefits | Died n=4† | Med ceased | Dose reduced | No change in med | Med to treat toxicity | ||||||
| Yes n=14 | No n=6 | NR n=15 | |||||||||
| Fatigue | 6 | 2 | 3 | 3 | 14 (15) | 2 (1–3) | 0 | 2 | 7 | 1 | 3 |
| Dizziness | 3 | 1 | 5 | 0 | 9 (10) | 1 (1–3) | 1 | 3 | 2 | 1 | 2 |
| Somnolence | 8 | 2 | 10 | 4 | 24 (26) | 1 (1–3) | 3 | 4 | 11 | 1 | 3 |
| Cognitive disturbance | 5 | 2 | 8 | 4 | 19 (20) | 2 (1–3) | 4 | 4 | 4 | 1 | 4 |
| Ataxia | 1 | 0 | 3 | 0 | 4 (4) | 1 (1–5) | 0 | 2 | 1 | 0 | 1 |
| Tremors | 0 | 1 | 2 | 1 | 4 (4) | 1 (1–3) | 0 | 2 | 1 | 1 | 0 |
| Nystagmus | 0 | 0 | 0 | 0 | 0 (0) | 0 (0) | 0 | 0 | 0 | 0 | 0 |
| Headache | 0 | 0 | 0 | 0 | 0 (0) | 0 (0) | 0 | 0 | 0 | 0 | 0 |
| Nausea | 2 | 1 | 4 | 0 | 7 (8) | 1.5 (1–3) | 1 | 1 | 2 | 2 | 1 |
| Suicidal ideation | 0 | 1 | 0 | 1 | 2 (2) | 2 (1–3) | 0 | 0 | 0 | 1 | 1 |
| Other | 3 | 2 | 4 | 1 | 10 (11) | 2 (1–3) | 1 | 1 | 4 | 3 | 1 |
| Total harms experienced | 93* (100) | ||||||||||
*Patients may experience more than one harm.
†Died before day 7.
NR, not reported.