Newly diagnosed acute myeloid leukaemia in combination with azacitidine Summary of the safety profile The most common adverse reactions were vomiting (40%), neutropenia (31%), thrombocytopenia (28%), electrocardiogram QT prolonged (21%), insomnia (19%).
The most common serious adverse reactions were differentiation syndrome (8%) and thrombocytopenia (3%). In patients treated with ivosidenib in combination with azacitidine, the frequency of discontinuation of ivosidenib due to adverse reactions was 6%.
Adverse reactions leading to discontinuation were electrocardiogram QT prolonged (1%), insomnia (1%), neutropenia (1%) and thrombocytopenia (1%). The frequency of dose interruption of ivosidenib due to adverse reactions was 35%. The most common adverse reactions leading to dose interruption were neutropenia (24%), electrocardiogram QT prolonged (7%), thrombocytopenia (7%), leukopenia (4%) and differentiation syndrome (3%).
The frequency of dose reduction of ivosidenib due to adverse reactions was 19%. Adverse reactions leading to dose reduction were electrocardiogram QT prolonged (10%), neutropenia (8%) and thrombocytopenia (1%). Tabulated list of adverse reactions The frequencies of adverse reactions are based on Study AG120-C-009 which included 72 patients with newly diagnosed AML randomised to and treated with ivosidenib (500 mg daily) in combination with azacitidine.
0 months). The adverse reaction frequencies are based on all-cause adverse event frequencies, where a proportion of the events for an adverse reaction may have other causes than ivosidenib, such as the disease, other medicinal products or unrelated causes.
Frequencies are defined as: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1 000 to < 1/100); rare (≥ 1/10 000 to < 1/1 000); very rare (< 1/10 000). Within each frequency grouping, adverse reactions are presented in the order of decreasing seriousness.
Table 2 - Adverse drug reactions reported in patients with newly diagnosed AML treated with ivosidenib in combination with azacitidine in clinical study AG120-C-009 (N=72) System organ class Frequency Adverse reactions Very common Differentiation syndrome, Leukocytosis, Thrombocytopenia, Neutropenia Blood and lymphatic system disorders Common Leukopenia Psychiatric disorders Very common Insomnia Very common Headache, DizzinessNervous system disorders Common Neuropathy peripheral Very common Vomiting1 Gastrointestinal disorders Common Oropharyngeal pain Musculoskeletal and connective tissue disorders Very common Pain in extremity, Arthralgia, Back pain Investigations Very common Electrocardiogram QT prolonged 1 Grouped term includes vomiting and retching.
Previously treated, locally advanced or metastatic cholangiocarcinoma Summary of the safety profile The most common adverse reactions were fatigue (43%), nausea (42%), abdominal pain (35%), diarrhoea (35%), decreased appetite (24%), ascites (23%), vomiting (23%), anaemia (19%) and rash (15%).
The most common serious adverse reactions were ascites (2%), hyperbilirubinemia (2%), and jaundice cholestatic (2%). In patients treated with ivosidenib, the frequency of treatment discontinuation due to adverse reactions was 2%. Adverse reactions leading to discontinuation were ascites (1%) and hyperbilirubinemia (1%).
The frequency of dose interruption of ivosidenib due to adverse reactions was 16%. The most common adverse reactions leading to dose interruption were hyperbilirubinemia (3%), alanine aminotransferase increased (3%), aspartate aminotransferase increased (3%), ascites (2%) and fatigue (2%).
The frequency of dose reduction of ivosidenib due to adverse reactions was 4%. Adverse reactions leading to dose reduction were electrocardiogram QT prolonged (3%) and neuropathy peripheral (1%). Tabulated list of adverse reactions The frequencies of adverse reactions are based on Study AG120-C-005 which included 123 patients with previously treated, locally advanced or metastatic cholangiocarcinoma, randomised to and treated with 500 mg ivosidenib once daily.
2) months). The adverse reaction frequencies are based on all-cause adverse event frequencies, where a proportion of the events for an adverse reaction may have other causes than ivosidenib, such as the disease, other medicinal products or unrelated causes.
Frequencies are defined as: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1 000 to < 1/100); rare (≥ 1/10 000 to < 1/1 000); very rare (< 1/10 000). Within each frequency grouping, adverse reactions are presented in the order of decreasing seriousness.
Table 3 - Adverse drug reactions reported in patients with locally advanced or metastatic cholangiocarcinoma treated with ivosidenib in clinical study AG120-C-005 (N=123) System organ class Frequency Adverse reactions Blood and lymphatic system disorders Very common Anaemia Metabolism and nutrition disorders Very common Decreased appetite Nervous system disorders Very common Neuropathy peripheral, Headache Gastrointestinal disorders Very common Ascites, Diarrhoea, Vomiting, Nausea, Abdominal pain Hepatobiliary disorders Common Jaundice cholestatic, Hyperbilirubinemia Skin and subcutaneous tissue disorders Very common Rash1 Very common FatigueGeneral disorders and administration site conditions Common Fall Very common Aspartate aminotransferase increased, Blood bilirubin increased Investigations Common Electrocardiogram QT prolonged, Alanine aminotransferase increased, White blood cell count decreased, Platelet count decreased 1 Grouped term includes rash, rash maculo-papular, erythema, rash macular, dermatitis exfoliative generalized, drug eruption, and drug hypersensitivity.
Description of selected adverse reactions Differentiation syndrome in patients with acute myeloid leukaemia (see […]