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LATITUDE: prespecified secondary and

exploratory endpoints

ADT+AA+P

(n = 597)

ADT+placebos

(n = 602)

Hazard Ratio

(95% CI)

P Value*

Secondary end points

Time to pain progression — mo

NR

16.6

0.70 (0.58–0.83) < 0.001

Time to PSA progression — mo

33.2

7.4

0.30 (0.26–0.35) < 0.001

Time to next symptomatic skeletal

event — mo

NR

NR

0.70 (0.54–0.92)

0.009

Time to chemotherapy — mo

NR

38.9

0.44 (0.35–0.56) < 0.001

Time to subsequent prostate cancer

therapy — mo

NR

21.6

0.42 (0.35–0.50) < 0.001

Exploratory end point

Patients with a PSA response

(decline ≥ 50% from baseline) — % 91

67

1.36 (1.28–1.45)

*

< 0.001

*

Value is odds ratio

§

The superiority of ADT+AA+P over ADT+placebos was observed for all secondary end points

Fizazi K et al. N Engl J Med 2017;377(4):352-360

LATITUDE: prespecified secondary and

exploratory endpoints

ADT+AA+P

(n = 597)

ADT+placebos

(n = 602)

Hazard Ratio

(95% CI)

Secondary end points

Time to pain progression — mo

NR

16.6

0.70 (0.58–0.83)

Time to PSA progression — mo

33.2

7.4

0.30 (0.26–0.35)

Time to next symptomatic skeletal

event — mo

NR

NR

0.70 (0.54–0.92)

Time to chemotherapy — mo

NR

38.9

0.44 (0.35–0.56)

Time

therapy — mo

NR

21.6

0.42 (0.35–0.50)

Exploratory end point

Patients with a PSA response

(decline ≥ 50% from baseline) — % 91

67

1.36 (1.28–1.45)

*

*

Value is odds ratio

§

The superiority of ADT+AA+P over ADT+placebos was observed for all secondary end poin

Fizazi K et al. N Engl J Med 2017