Clinical Data
Tolerability
Cardiac AEs
The cardiac AE rate (regardless of investigator-assessed causality) was higher in subjects receiving PREVYMIS (13%) compared to subjects receiving placebo (6%). The most common cardiac AEs were tachycardia (reported in 4% of PREVYMIS subjects and in 2% of placebo subjects) and atrial fibrillation (reported in 3% of PREVYMIS subjects and in 1% of placebo subjects). Among those subjects who experienced 1 or more cardiac AEs, 85% of PREVYMIS and 92% of placebo subjects had events reported as mild or moderate in severity.
All grade AEs reported in ≥10% of patients treated with PREVYMIS at a frequency at least 2% greater than placebo
AEs | PREVYMIS (n=373) | Placebo (n=192) |
---|---|---|
Nausea | 27% | 23% |
Diarrhea | 26% | 24% |
Vomiting | 19% | 14% |
Peripheral edema | 14% | 9% |
Cough | 14% | 10% |
Headache | 14% | 9% |
Fatigue | 13% | 11% |
Abdominal pain | 12% | 9% |
Drug-related renal and hepatic AEs1
AEs | PREVYMIS | Placebo |
---|---|---|
Renal and urinary disorders | 1% | 1% |
Hepatobiliary disorders | 0% | 1% |
Rates of discontinuation due to AEs were comparable between PREVYMIS and placebo (13% vs 12%, respectively)1
No differences in incidence of or time to engraftmenta between PREVYMIS and placebo
(a) Engraftment was defined as an absolute neutrophil count ≥500/mm3 on 3 consecutive days after transplantation.