Safety Profile of HTX-019 Administered as an Intravenous Infusion in Patients With Cancer: A Retrospective Analysis.
George Calcanes, Jeffrey L Vacirca
PMID 31464835WHAT IT FOUND
In 147 cancer patients receiving chemotherapy, 864 doses of HTX-019 IV were given with no infusion-site adverse events and no adverse events judged related to HTX-019.
This is safety evidence, not proof the antiemetic works.
Key findings
01Nine of 147 patients had 14 adverse events, and none were attributed to HTX-019.
02No infusion-site adverse events were reported.
03Feeling hot was the most common adverse event, occurring in 4 patients.
STILL TO COME
How it was doneWhat they foundWhat it means for RNs
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What it does not show
The study was retrospective and relied on existing records. Only patients who received at least 4 doses of HTX-019 were included. Patients received HTX-019, a 5-hydroxytryptamine type 3 receptor antagonist, dexamethasone, and chemotherapy, so the contribution of any single component cannot be separated. The analysis was designed to detect specific hypersensitivity and infusion-site adverse events from predetermined nursing and medical documentation, so other adverse event types may not have been analyzed or accounted for.
The easy way to misread this
Do not read this as proof that HTX-019 caused no adverse events. Nine of 147 patients had 14 adverse events, and none were attributed to HTX-019 because chemotherapy began at least 50 minutes after HTX-019 started and all events occurred after chemotherapy began. Patients received HTX-019, a 5-hydroxytryptamine type 3 receptor antagonist, dexamethasone, and chemotherapy, so the contribution of any single component cannot be separated.