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Patient Fitness in AML
The content of this website has been produced in line with the MYLOTARG®▼ (gemtuzumab ozogamicin) Summary of Product Characteristics for Great Britain and is intended for Healthcare Professionals based in Great Britain. For MYLOTARG®▼ (gemtuzumab ozogamicin) and cytarabine Prescribing Information Click here. Adverse event reporting information can be found at the bottom of the page.
|
MYLOTARG + Chemotherapy (n=131) |
Standard Chemotherapy (n=137) |
|||
|---|---|---|---|---|
|
System organ class |
Very common |
Common |
Very common (≥ 10%) |
Common |
|
Infections and infestations† |
Infection (77.9%)‡ |
Infection (77.4%)‡ |
||
|
Vascular disorders† |
Haemorrhage (90.1%)§ |
Haemorrhage (78.1%)§ |
||
|
Hepatobiliary disorders |
Increased AST (89.2%)¶, increased ALT (78.3%)¶, hyperbilirubinaemia (51.6%)¶ |
Veno-occlusive liver disease (4.6%)†ǁ |
Increased AST (73.9%)¶, increased ALT (81.3%)¶, hyperbilirubinaemia (50.8%)¶ |
Veno-occlusive liver disease (1.5%)ǁ |
|
Blood and lymphatic disorders¶ |
Haemoglobin decreased (100%), thrombocytopenia (100%), leukopenia (100%), lymphopenia (98.5%), neutropenia (97.7%), increased PT (84.8%), prolonged aPTT (80%) |
Haemoglobin decreased (100%), thrombocytopenia (100%), leukopenia (99.3%), lymphopenia (97.8%), neutropenia (98.5%), increased PT (89.1%), prolonged aPTT (57.5%) |
||
|
Metabolism and nutrition disorders¶ |
Hyperglycaemia (92.0%), hyperuricaemia (32.5%) |
Hyperglycaemia (91.1%), hyperuricaemia (28.5%) |
||
|
Investigations¶ |
Increased ALP (79.7%) |
Increased ALP (68.9%) |
|
|
Table adapted from: MYLOTARG Summary of Product Characteristics
*Only selected safety data were collected in this study of newly-diagnosed AML. All-grade events.
†Including fatal outcome. Fatal outcomes associated with VOD were observed in patients in the MYLOTARG + SC arm, not in the SC arm.2
‡Includes sepsis and bacteraemia (53.4%), fungal infection (15.3%), lower respiratory tract infection (5.3%), bacterial infection (9.2%),
gastrointestinal infection (8.4%), skin infection (2.3%), other infections (28.4%).
§Includes central nervous system haemorrhage (3.1%), upper gastrointestinal haemorrhage (33.6%), lower gastrointestinal haemorrhage (17.6%), subcutaneous haemorrhage (60.3%), other haemorrhage (64.9%), and epistaxis (62.6%).
¶Frequency is based on laboratory values (Grade per NCI CTCAE v4.0.3).
IIVeno-occlusive liver disease includes the following reported preferred terms: Veno-occlusive disease and veno-occlusive liver disease.
Serious adverse events that occurred during treatment
|
Adverse event |
MYLOTARG + chemotherapy |
Standard Chemotherapy |
|---|---|---|
|
Grade ≥ 3, % |
Grade ≥ 3, % |
|
|
Thrombocytopenia |
100 |
100 |
|
Leukopenia |
100 |
99.3 |
|
Neutropenia |
96.1 |
97.0 |
|
Lymphopenia |
90.7 |
89.6 |
|
Haemoglobin decreased |
86.2 |
89.7 |
|
Infection*‡ |
76.3 |
74.4 |
|
Haemorrhage*‡ |
20.6 |
8.8 |
|
Hyperglycaemia |
19.2 |
17.8 |
|
Increased AST |
14.0 |
9.0 |
|
Increased ALP |
13.3 |
5.3 |
|
Increased ALT |
10.9 |
15.7 |
Table adapted from: MYLOTARG Summary of Product Characteristics.
*Including fatal outcome. †Infection includes sepsis and bacteraemia (53.4%), fungal infection (15.3%), lower respiratory tract infection (5.3%), bacterial infection (9.2%), gastrointestinal infection (8.4%), skin infection (2.3%) and other infections (28.4%). ‡Haemorrhage includes central nervous system haemorrhage (3.1%), upper gastrointestinal haemorrhage (33.6%), lower gastrointestinal haemorrhage (17.6%), subcutaneous haemorrhage (60.3%), other haemorrhage (64.9%) and epistaxis (62.6%).
Watch Professor Robert Hills discuss the key clinical data from the pivotal ALFA study.
Watch Dr. Sreetharan Munisamy discuss the current treatment landscape for de novo AML in Video 1 of the Key Topics in the Management of de novo AML video series. Click the link below to explore the rest of the on-demand series.
Watch Dr. Sreetharan Munisamy discuss the current treatment landscape for de novo AML in Video 1 of the Key Topics in the Management of de novo AML video series. Click the link below to find out about the rest of the on-demand series.
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