Table 3

Serious adverse events considered possibly related to study drug in SHEPHERD and their occurrence in placebo-treated patients from TRIUMPH

Serious adverse eventPatients, no. (%)
SHEPHERD* eculizumab
TRIUMPH† placebo
52 wk, n = 971st 26 wk, n = 972nd 26 wk, n= 9626 wk, n = 44
Pyrexia 2 (2.1) 1 (1.0) 1 (1.0) (2.3) 
Headache 1 (1.0) 1 (1.0) 0 (0.0) 
Abdominal distension 1 (1.0) 0 1 (1.0) (0.0) 
Viral infection 1 (1.0) 0 1 (1.0) (2.3) 
Anxiety 1 (1.0) 1 (1.0) 0 (0.0) 
Renal impairment 1 (1.0) 1 (1.0) 0 (0.0) 
Serious adverse eventPatients, no. (%)
SHEPHERD* eculizumab
TRIUMPH† placebo
52 wk, n = 971st 26 wk, n = 972nd 26 wk, n= 9626 wk, n = 44
Pyrexia 2 (2.1) 1 (1.0) 1 (1.0) (2.3) 
Headache 1 (1.0) 1 (1.0) 0 (0.0) 
Abdominal distension 1 (1.0) 0 1 (1.0) (0.0) 
Viral infection 1 (1.0) 0 1 (1.0) (2.3) 
Anxiety 1 (1.0) 1 (1.0) 0 (0.0) 
Renal impairment 1 (1.0) 1 (1.0) 0 (0.0) 
*

There were no SAEs in SHEPHERD that were deemed probably or definitely related to study drug.

†

TRIUMPH was a phase 3, double-blind, placebo-controlled, international study of eculizumab treatment in patients with PNH.7  The inclusion criteria for TRIUMPH were different from those of SHEPHERD.

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