Table 2.

AE listings deemed to be possibly or probably related to SRT501/placebo intervention

SRT501 (N = 6)Placebo (N = 3)
AENo. of eventsNo. of patientsNo. of eventsNo. of patients
GI disorders12521
 Anal pruritus1100
 Diarrhea7521
 Nausea4100
General disorders1100
 Chills1100
 Nervous system disorders1111
 Lethargy0011
 Peripheral neuropathy1100
Skin/tissue disorders2200
 Rash1100
 Skin irritation1100
 Vascular disorders1100
 Flushing1100