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.