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. 2024 May 31;9(4):1311–1320. doi: 10.1002/epi4.12967

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%)