Abiraterone Acetate (Page 5 of 11)

LATITUDE

Patients with Metastatic High-Risk CSPC

LATITUDE enrolled 1199 patients with newly-diagnosed metastatic, high-risk CSPC who had not received prior cytotoxic chemotherapy. Patients were ineligible if AST and/or ALT ≥ 2.5 x ULN or if they had liver metastases. All the patients received GnRH analogs or had prior bilateral orchiectomy during the trial. The median duration of treatment with abiraterone acetate tablets and prednisone was 24 months.

Table 5 shows adverse reactions on the abiraterone acetate tablets arm that occurred in ≥ 5% of patients with a ≥ 2% absolute increase in frequency compared to those on the placebos arm.

Table 5: Adverse Reactions in ≥ 5% of Patients on the Abiraterone Acetate Tablets Arm in LATITUDE *
*
All patients were receiving an GnRH agonist or had undergone orchiectomy.
Adverse events graded according to CTCAE version 4.0
Reported as an adverse event or reaction
§
Including cough, productive cough, upper airway cough syndrome

System/Organ Class

Adverse reaction

Abiraterone Acetate Tablets with Prednisone

(N = 597)

Placebos

(N = 602)

All Grades

%

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

16

5.5

13

1.3

Aspartate aminotransferase increased

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 §

6.5

0.0

3.2

0

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

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

Laboratory Abnormality

Abiraterone Acetate Tablets with Prednisone

(N = 597)

Placebos

(N= 602)

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

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