Abiraterone (Page 5 of 12)

Table 5: Adverse Reactions in ≥5% of Patients on the Abiraterone Acetate Arm in LATITUDE 1

Abiraterone Acetate with Prednisone

(N = 597)

Placebos

(N = 602)

System/Organ Class

Adverse reaction

All Grades 2 % Grade 3-4 % All Grades % Grade 3-4 %
Vascular disorders
Hypertension 37 20 13 10
Hot flush 15 0.0 13 0.2
Metabolism and nutrition disorders
Hypokalemia 20 10 3.7 1.3
Investigations
Alanine aminotransferase increased 3 16 5.5 13 1.3
Aspartate aminotransferase increased 3 15 4.4 11 1.5
Infections and infestations
Urinary tract infection 7.0 1.0 3.7 0.8
Upper respiratory tract infection 6.7 0.2 4.7 0.2
Nervous system disorders
Headache 7.5 0.3 5.0 0.2
Respiratory, Thoracic and Mediastinal Disorders
Cough 4 6.5 0.0 3.2 0

1 All patients were receiving an GnRH agonist or had undergone orchiectomy.

2 Adverse events graded according to CTCAE version 4.0.

3 Reported as an adverse event or reaction.

4 Including cough, productive cough, upper airway cough syndrome

Table 6 shows laboratory abnormalities that occurred in >15% of patients, and more frequently (>5%) in the abiraterone acetate arm compared to placebos.

Table 6: Laboratory Abnormalities in >15% of Patients in the Abiraterone Acetate Arm of LATITUDE

Abiraterone Acetate with Prednisone

(N=597)

Placebos

(N=602)

Laboratory Abnormality Grade 1-4 % Grade 3-4 % Grade 1-4 % Grade 3-4 %
Hematology
Lymphopenia 20 4.1 14 1.8
Chemistry
Hypokalemia 30 9.6 6.7 1.3
Elevated ALT 46 6.4 45 1.3
Elevated total bilirubin 16 0.2 6.2 0.2

Cardiovascular Adverse Reactions

In the combined data of randomized, placebo-controlled clinical studies, cardiac failure occurred more commonly in patients on the abiraterone acetate arm compared to patients on the placebo arm (2.6% versus 0.9%). Grade 3-4 cardiac failure occurred in 1.3% of patients taking abiraterone acetate and led to 5 treatment discontinuations and 4 deaths. Grade 3-4 cardiac failure occurred in 0.2% of patients taking placebo. There were no treatment discontinuations and two deaths due to cardiac failure in the placebo group.

In the same combined data, the majority of arrhythmias were grade 1 or 2. There was one death associated with arrhythmia and three patients with sudden death in the abiraterone acetate arms and five deaths in the placebo arms. There were 7 (0.3%) deaths due to cardiorespiratory arrest in the abiraterone acetate arms and 2 (0.1%) deaths in the placebo arms. Myocardial ischemia or myocardial infarction led to death in 3 patients in the placebo arms and 3 deaths in the abiraterone acetate arms.

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