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Jakavi · 4.8 · 19 In the comparative period of phase 3 studies in PV patients, bleeding events (including intracranial and ga
Eintrag öffnenJakavi · 4.8 · 20 12.5% (grade ≥3, 11.1%) of patients in the ruxolitinib arm compared to 8.7% (grade ≥3, 6.0%) in the BAT arm
Eintrag öffnenJakavi · 4.8 · 21 Increased systolic blood pressure In the phase 3 pivotal clinical studies in MF an increase in systolic blo
Eintrag öffnenJakavi · 4.8 · 44 Discontinuation due to adverse events, regardless of causality, was observed in 29.4% of patients in REACH2
Eintrag öffnenJakavi · 4.8 · 45 Adverse drug reactions from clinical studies in acute and chronic GvHD (Table 5) are listed by MedDRA syste
Eintrag öffnenJakavi · 4.8 · 46 Gastrointestinal disorders Increased lipase1 -6 -6 Very common Very common 6 CTCAE grade 3 - -6 Common Comm
Eintrag öffnenJakavi · 4.8 · 47 Neutropenia In the phase 3 acute GvHD study (REACH2), grade 3 and 4 neutropenia was observed in 17.9% and 2
Eintrag öffnenJakavi · 4.8 · 48 Elevated lipase In the comparative period of the phase 3 acute GvHD study (REACH2), new or worsened lipase
Eintrag öffnenJakavi · 4.8 · A total of 106 patients aged 2 to <18 years with GvHD were analysed for safety: 51 patients (45 patients in RE
Eintrag öffnenJakavi · 4.8 · Acute GvHD Chronic Chronic GvHD Acute GvHD (Paediatric GvHD (Paediatric (REACH2) pool) (REACH3) pool) Frequenc
Eintrag öffnenJakavi · 4.8 · Acute GvHD Chronic Chronic GvHD Acute GvHD (Paediatric GvHD (Paediatric (REACH2) pool) (REACH3) pool) Frequenc
Eintrag öffnenJakavi · 4.8 · Acute GvHD The most frequently reported adverse drug reactions in REACH2 (adult and adolescent patients) were
Eintrag öffnenJakavi · 4.8 · Acute GvHD The most frequently reported adverse drug reactions in REACH2 (adult and adolescent patients) were
Eintrag öffnenJakavi · 4.8 · Adverse drug reaction Frequency category for MF Frequency category for PV patients patients Infections and inf
Eintrag öffnenJakavi · 4.8 · Adverse drug reactions from clinical studies in MF and PV (Table 6) and in acute and chronic GvHD (Table 7) ar
Eintrag öffnenJakavi · 4.8 · Anaemia In phase 3 clinical studies in MF, median time to onset of first CTCAE grade 2 or higher anaemia was 1
Eintrag öffnenJakavi · 4.8 · Anaemia In the phase 3 acute (REACH2) and chronic (REACH3) GvHD studies, anaemia (all grades) was reported in
Eintrag öffnenJakavi · 4.8 · Anaemia, thrombocytopenia and neutropenia are dose-related effects.
Eintrag öffnenJakavi · 4.8 · Bleeding In the comparative period of the phase 3 acute GvHD study (REACH2), bleeding events were reported in
Eintrag öffnenJakavi · 4.8 · Bleeding In the phase 3 pivotal studies in MF bleeding events (including intracranial and gastrointestinal, br
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