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Rozlytrek · 4.8 · 14 Table 5: Adverse drug reactions occurring in paediatric patients treated with Rozlytrek in clinical trials
Eintrag öffnenRozlytrek · 4.8 · 15 Infants and Children2 Adolescents3 All System organ toddlers1 (n=55) (n=15) paediatric Frequency class (n=2
Eintrag öffnenRozlytrek · 4.8 · 16 Infants and Children2 Adolescents3 All System organ toddlers1 (n=55) (n=15) paediatric Frequency class (n=2
Eintrag öffnenRozlytrek · 4.8 · 17 Infants and Children2 Adolescents3 All System organ toddlers1 (n=55) (n=15) paediatric Frequency class (n=2
Eintrag öffnenRozlytrek · 4.8 · 18 Syncope Syncope was reported in 5.0% of patients. In some patients, syncope was reported with concurrent hy
Eintrag öffnenRozlytrek · 4.8 · 4 Dysaesthesia (paresthesia, hyperesthesia, hypoesthesia, dysesthesia) 5 Cognitive disorders (cognitive disord
Eintrag öffnenRozlytrek · 4.8 · 44 Frequency System organ All grades Grade ≥3 Adverse reaction category class (%) (%) (all grades) Arthralgia
Eintrag öffnenRozlytrek · 4.8 · 45 Table 5: Adverse drug reactions occurring in paediatric patients treated with Rozlytrek in clinical trials
Eintrag öffnenRozlytrek · 4.8 · 46 Infants and Children2 Adolescents3 All paediatric System organ Frequency toddlers1 (n=55) (n=15) patients c
Eintrag öffnenRozlytrek · 4.8 · 47 Infants and Children2 Adolescents3 All paediatric System organ Frequency toddlers1 (n=55) (n=15) patients c
Eintrag öffnenRozlytrek · 4.8 · 48 (0.2%), visual hallucination (0.2%), auditory hallucination (0.1%), mental impairment (0.1%) and mental dis
Eintrag öffnenRozlytrek · 4.8 · 49 to 49.61 months). The median duration of eye disorders was 1.2 months (range 0.03 months to 14.98 months).
Eintrag öffnenRozlytrek · 4.8 · A total of 52 fracture events were reported in 27 paediatric patients, with 14 patients who experienced more t
Eintrag öffnenRozlytrek · 4.8 · A total of 52 fracture events were reported in 27 paediatric patients, with 14 patients who experienced more t
Eintrag öffnenRozlytrek · 4.8 · Adverse drug reactions are listed by MedDRA system organ class. The following categories of frequency have bee
Eintrag öffnenRozlytrek · 4.8 · Adverse drug reactions are listed by MedDRA system organ class. The following categories of frequency have bee
Eintrag öffnenRozlytrek · 4.8 · Adverse reactions and laboratory abnormalities of Grade 3 or 4 severity occurring more frequently (at least a
Eintrag öffnenRozlytrek · 4.8 · Adverse reactions and laboratory abnormalities of Grade 3 or 4 severity occurring more frequently (at least a
Eintrag öffnenRozlytrek · 4.8 · Among the 853 patients who received entrectinib across clinical trials, 227 (26.6%) patients were 65 years or
Eintrag öffnenRozlytrek · 4.8 · Ataxia Ataxia (including events of ataxia, balance disorder, and gait disturbances) was reported in 15.1% of p
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