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Alecensa · 4.8 · 11 while diarrhoea was reported in 2 patients (1.3 %) in the alectinib arm; the incidence of Grade 3 and 4 eve
Eintrag öffnenAlecensa · 4.8 · 8 phase II clinical trials (NP28761, NP28673; N = 253), the median duration of exposure to Alecensa was 11.2 m
Eintrag öffnenAlecensa · 4.8 · 9 System organ class Alecensa ADRs (MedDRA) N = 533 Frequency category Frequency category (all grades) (grades
Eintrag öffnenAlecensa · 4.8 · Adverse reactions of bilirubin elevations were reported in 25.9 % of the patients treated with Alecensa across
Eintrag öffnenAlecensa · 4.8 · Bradycardia Cases of bradycardia (11.3 %) of Grade 1 or 2 have been reported in patients treated with Alecensa
Eintrag öffnenAlecensa · 4.8 · Concurrent elevations in ALT or AST greater than or equal to three times the ULN and total bilirubin greater t
Eintrag öffnenAlecensa · 4.8 · Description of selected adverse drug reactions
Eintrag öffnenAlecensa · 4.8 · Gastrointestinal effects Constipation (39.6 %), diarrhoea (18.8 %), nausea (17.6 %), and vomiting (12.4 %) wer
Eintrag öffnenAlecensa · 4.8 · Haemolytic anaemia Haemolytic anaemia has been observed in 3.1 % of patients treated with Alecensa in the clin
Eintrag öffnenAlecensa · 4.8 · Hepatotoxicity Across clinical trials, three patients had a documented drug-induced liver injury (including tw
Eintrag öffnenAlecensa · 4.8 · In BO40336 (ALINA; N = 128), the median duration of exposure to Alecensa was 23.9 months. In BO28984 (ALEX; N
Eintrag öffnenAlecensa · 4.8 · Interstitial lung disease (ILD) / pneumonitis Across clinical trials, ILD/pneumonitis occurred in 1.7 % of pat
Eintrag öffnenAlecensa · 4.8 · Patients should be monitored for liver function including ALT, AST, and total bilirubin as outlined in section
Eintrag öffnenAlecensa · 4.8 · Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medi
Eintrag öffnenAlecensa · 4.8 · Severe myalgia and CPK elevations Cases of myalgia (35.3 %) including myalgia events (24.2 %), arthralgia (16.
Eintrag öffnenAlecensa · 4.8 · Summary of the safety profile
Eintrag öffnenAlecensa · 4.8 · Table 3 ADRs reported in Alecensa clinical trials (BO40336, BO28984, NP28761, NP28673; N = 533) System organ c
Eintrag öffnenAlecensa · 4.8 · Tabulated list of adverse drug reactions Table 3 lists the ADRs occurring in patients who received Alecensa ac
Eintrag öffnenAlecensa · 4.8 · The ADRs listed in Table 3 are presented by system organ class and frequency categories, defined using the fol
Eintrag öffnenAlecensa · 4.8 · The data described below reflect exposure to Alecensa in 533 patients with resected or advanced ALK-positive N
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