TABLE 3.
Adverse events (AE) during the follow‐up period.
3rd line (N = 345) | Fourth line till end of follow‐up (N = 187) | ||
---|---|---|---|
Individuals with ≥1 AEs, n (%) | 132 (38.3%) | Individuals with ≥1 AEs, n (%) | 85 (45.5%) |
Numbers of AEs reported | Numbers of AEs reported | ||
Mean (standard deviation) | 3.9 (4.1) | Mean (standard deviation) | 4.1 (4.0) |
Median (interquartile range) | 2.0 [1.0–4.5] | Median (interquartile range) | 2.0 [1.0–5.0] |
Nervous system AE | 123 (35.7%) | Nervous system AE | 75 (40.1%) |
Headache | 51 (14.8%) | Headache | 35 (18.7%) |
Somnolence | 43 (12.5%) | Asthenia | 28 (15.0%) |
Dizziness | 38 (11.0%) | Fatigue | 21 (11.2%) |
Fatigue | 38 (11.0%) | Somnolence | 21 (11.2%) |
Asthenia | 24 (7.0%) | Dizziness | 18 (9.6%) |
Tremor | 21 (6.1%) | Tremor | 17 (9.1%) |
Irritability | 20 (5.8%) | Blurred vision | 16 (8.6%) |
Cognitive dysfunction | 16 (4.6%) | Diplopia | 13 (7.0%) |
Diplopia | 15 (4.3%) | Cognitive dysfunction | 8 (4.3%) |
Ataxia | 11 (3.2%) | Irritability | 8 (4.3%) |
Blurred vision | 9 (2.6%) | Ataxia | 7 (3.7%) |
Aggression | 5 (1.4%) | Aggression | 4 (2.1%) |
Motor incoordination | 2 (0.6%) | Motor incoordination | 2 (1.1%) |
Worsened depression/suicidal ideation | 1 (0.3%) | Worsened depression/suicidal ideation | 0 (0.0%) |
Gastrointestinal system AE | 73 (21.2%) | Gastrointestinal system AE | 48 (25.7%) |
Nausea | 31 (9.0%) | Diarrhea | 22 (11.8%) |
Diarrhea | 29 (8.4%) | Vomiting | 21 (11.2%) |
Abdominal pain | 27 (7.8%) | Abdominal pain | 19 (10.2%) |
Anorexia | 25 (7.2%) | Anorexia | 16 (8.6%) |
Vomiting | 23 (6.7%) | Nausea | 16 (8.6%) |
Weight gain | 13 (3.8%) | Weight gain | 10 (5.3%) |
Respiratory system AE | 26 (7.5%) | Respiratory system AE | 19 (10.2%) |
Flu syndrome | 19 (5.5%) | Flu syndrome | 11 (5.9%) |
Rhinitis | 14 (4.1%) | Rhinitis | 9 (4.8%) |
Infection | 8 (2.3%) | Infection | 5 (2.7%) |
Pharyngitis | 3 (0.9%) | Pharyngitis | 3 (1.6%) |
Other AE | 25 (7.2%) | Other AE | 15 (8.0%) |
Lab abnormalities | 11 (3.2%) | Lab abnormalities | 7 (3.7%) |
Renal dysfunction | 10 (2.9%) | Rash | 6 (3.2%) |
Rash | 9 (2.6%) | Renal dysfunction | 5 (2.7%) |
Tremor, hyponatremia, and insomnia | 3 (0.9%) | Hyponatremia and insomnia | 2 (1.1%) |