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AE, %

ADT + AAP

(n = 597)

ADT + placebos

(n = 602)

Grade 3

Grade 4

Grade 3

Grade 4

Hypertension

20

0

10

0.2

Hypokalaemia

10

0.8

1

0.2

ALT increase

5

0.3

1

0

AST increase

4

0.2

1

0

Hyperglycaemia

4

0.2

3

0

Bone pain

3

0

3

0

Cardiac events

3

0.8

1

0

Anaemia

2

0.5

4

0.2

Back pain

2

0

3

0

Fatigue

2

0

2

0

Spinal cord

compression

2

0

1

0.5

Safety: CHAARTED and LATITUDE

1. Sweeney C, et al. N Engl J Med. 2015;373:737-46.

AE

Grade 3 Grade 4 Grade 5

Patients, n (%)

Allergic reaction

7 (1.8) 1 (0.3) 0

Fatigue

16 (4.1) 0

0

Diarrhoea

4 (1.0) 0

0

Stomatitis

2 (0.5) 0

0

Neuropathy, motor

2 (0.5) 0

0

Neuropathy, sensory

2 (0.5) 0

0

Thromboembolism

1 (0.3) 2 (0.5) 0

Suddent death

0

0

1 (0.3)

Anaemia

4 (1.0) 1 (0.3) 0

Thromocytopenia

0

1 (0.3) 0

Neutropenia

12 (3.1) 35 (9.0) 0

Febrile neutropenia

15 (3.8) 9 (2.3) 0

Infections with neutropenia

5 (1.3) 4 (1.0) 0

Any event

65 (16.7) 49 (12.6) 1 (0.3)

CHAARTED

1

LATITUDE

2

AE, adverse event; ALT, alanine transaminase; AST, aspartate aminotransferase.

AE, %

Gra

Hypertension

2

Hypokalaemia

1

ALT increase

AST increase

Hyperglycaemia

Bone pain

Cardiac events

Anaemia

Back pain

Fatigue

Spinal cord

compression

Safety: CHAARTED and LATITUDE

1. Sween

AE

Grade 3 Grade 4 Grade 5

Patients, n (%)

Allergic reaction

7 (1.8) 1 (0.3) 0

Fatigue

16 (4.1) 0

0

Diarrhoea

4 (1.0) 0

0

Stomatitis

2 (0.5) 0

0

Neuropathy, motor

2 (0.5) 0

0

Neuropathy, sensory

2 (0.5) 0

0

Thromboembolism

1 (0.3) 2 (0.5) 0

Suddent death

0

0

1 (0.3)

Anaemia

4 (1.0) 1 (0.3) 0

Thromocytopenia

0

1 (0.3) 0

Neutropenia

12 (3.1) 35 (9.0) 0

Febrile neutropenia

15 (3.8) 9 (2.3) 0

Infections with neutropenia

5 (1.3) 4 (1.0) 0

Any event

65 (16.7) 49 (12.6) 1 (0.3)

CHAARTED

1

LA

AE, adverse vent; ALT, alanine transaminase; AST, aspartate aminotransferase.