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Adverse events in PROSPER and SPARTAN
SPARTAN
1
PROSPER
2
APA
(n = 803)
PBO
(n = 398)
ENZA
(n = 933)
PBO
(n = 468)
Safety
AE reporting every 4 weeks
AE reporting every 4 months
AEs, %
Any grade
97%
93%
87%
77%
Grade ≥ 3
45%
34%
31%
23%
Serious AEs
25%
23%
24%
18%
AEs leading to discontinuation
11%
7%
9%
6%
AEs leading to death
1.2% (n=10)
0.3% (n=1)
1% (n=9)
0.6% (n=3)
Major CV event
1
1
5
3
Seizures
0.24% (n= 2)
0
0.32 % (n = 3)
0
1. Smith MR, et al. N Engl J Med 2018.
2. Hussain M, et al. N Engl J Med 2018