Table 2 Treatment-emergent adverse events.

Adverse events reported by healthy volunteers dosed for either a single or multiple (14 days) days of dosing with SYNB1020. All reported adverse events were of mild or moderate severity. QD, once daily; TEAE, treatment-emergent adverse event.

System organ
class
preferred term
Single-day cohortsMultiple-day cohortsPooled placebo
cohorts
2 × 109
CFU QD
(N = 3)
n (%)
2 × 1010
CFU QD
(N = 3)
n (%)
2 × 1011
CFU QD
(N = 3)
n (%)
2 × 1012
CFU QD
(N = 3)
n (%)
5 × 1011
CFU TID
(N = 3)
n (%)
1 × 1012
CFU TID
(N = 3)
n (%)
2 × 1012
CFU TID
(N = 3)
n (%)
2 × 109
CFU TID
(N = 6)
n (%)
2 × 1011
CFU TID
(N = 6)
n (%)
5 × 1011
CFU TID
(N = 6)
n (%)
SAD
part
(N = 7)
n (%)
MAD
part
(N = 6)
n (%)
Any TEAE0002 (67)1 (33)1 (33)2 (67)05 (83)2 (33)01 (17)
GI disorders0002 (67)01 (33)2 (67)03 (50)2 (33)01 (17)
  Nausea0001 (33)01 (33)2 (67)02 (33)2 (33)00
  Abdominal
pain
0001 (33)00002 (33)1 (17)00
  Vomiting000001 (33)2 (67)001 (17)00
  Abdominal
discomfort
000000001 (17)1 (17)00
  Abdominal
distension
0001 (33)00000000
  Diarrhea0000000001 (17)00
  Flatulence000000000001 (17)
General disorders
and
administration
site conditions
0002 (67)00002 (33)1 (17)01 (17)
  Catheter site
swelling
0002 (67)00000001 (17)
  Vessel
puncture site
pain
0001 (33)000001 (17)00
  Catheter site
bruise
000000001 (17)000
  Catheter site
pain
0001 (33)00000000
  Vessel
puncture site
bruise
000000001 (17)000
Infections and
infestations
00001 (33)0000000
  Upper
respiratory
tract infection
00001 (33)0000000
Nervous system
disorders
0000000001 (17)00
  Headache0000000001 (17)00