PALOMA-3 AEs 

AEs Reported in PALOMA-3 (Safety Population)¹

Adapted from Cristofanilli M, et al. 2016.^{1​​​​}

Grading according to CTCAE 4.0 and MedDRA 18.0. Clustered PTs were used for some AEs. Anaemia was defined as any event having a PT that equals to anaemia or haematocrit decreased or haemoglobin decreased. Hyperglycaemia is any event having a PT that equals blood glucose increased or diabetes mellitus or diabetes mellitus inadequate control or glycosylated haemoglobin increased or hyperglycaemia or type 1 diabetes mellitus or type 2 diabetes mellitus. Infection is defined as any event having a PT of the System Organ Class Infections and infestations. Leukopenia is any event having a PT that equals leukopenia or WBC count decreased. Lymphopenia is any event having a PT that equals lymphocyte count decreased or lymphopenia. Neutropenia is any event having a PT that equals neutropenia or neutrophil count decreased. Rash is any event having a PT that equals dermatitis or dermatitis acneiform or rash or rash erythematous or rash maculopapular or rash papular or rash pruritic. Pulmonary embolism is any event having a PT that equals pulmonary artery thrombosis or pulmonary embolism. Thrombocytopenia is any event having a PT that equals platelet count decreased or thrombocytopenia.

Data cut-off date: 16 March 2015. Data are n (%) unless otherwise specified.¹

*One other case of pleural effusion that was not graded also occurred in the PALBACE® + FUL group.
^†Reported causes of death were neutropenic sepsis, multiple organ failure and disease progression based on latest site follow-up information.

AE, adverse event; ALT, alanine transaminase; CTCAE, Common Terminology Criteria for Adverse Events; LET, letrozole; MedDRA, Medical Dictionary for Regulatory Activities; n, number of patients; PLA, placebo; PT, preferred term; WBC, white blood cell.

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