Serious adverse events and fat-soluble vitamin deficiency with Bylvay1,2
|
ASSERT 1: Rates of Serious Adverse Events (SAEs)1
|
|
Patients With Any
|
Placebo
(N=17)
n (%)
|
Bylvay
120 mcg/kg/day
(N=35)
n (%)
|
|
Treatment-emergent SAEs
|
2 (12)
|
5 (14)
|
|
Drug-related treatment-
emergent SAEs
|
0
|
1 (3)
|
|
- Treatment-emergent SAEs in the placebo group included: pyrexia, subcutaneous abscess, cerumen impaction, otitis media chronic, adenoidal hypertrophy
- Drug-related treatment-emergent SAEs in the odevixibat group related to treatment included: hematemesis and international normalized ratio increased
- There were no discontinuations
- No deaths were reported
Common adverse reactions (>5%)
reported in ASSERT 1
trial2
|
ASSERT 1: Clinical Adverse Reactions (≥5%)
|
|
Preferred Term
|
Placebo
(N=17)
n (%)
|
Bylvay
120 mcg/kg/day
(N=35)
n (%)
|
|
Diarrhea
|
1 (6)
|
10 (29)
|
|
Abdominal pain
|
1 (6)
|
5 (14)
|
|
Hematoma
|
0
|
3 (9)
|
|
Weight decreased
|
0
|
2 (6)
|
|
- Most treatment-emergent adverse events were mild to moderate in severity1
- All reports of diarrhea were grade 1 intensity (mild)1
- Treatment-related diarrhea was reported in1
- 1 patient receiving Bylvay (duration: 4 days)
- 1 patient receiving placebo (duration: 24 days)
- In ASSERT 2, treatment-emergent adverse reactions were similar to those observed in ASSERT 1. The most common reason for Bylvay treatment interruption was gastrointestinal disorders, including diarrhea and abdominal pain2
