Nebenwirkungen · Defitelio
Defitelio 80 mg/mL concentrate for solution for infusion · Abschnitt 4.8 · PDF-Seite 5
HOS-215468 · Präparat HOS-155442
The safety evaluation of defibrotide is based on the safety pooled data set, which included patients who received 25 mg/kg/day of defibrotide for the treatment of VOD, from 4 clinical studies: The Phase 3 pivotal treatment study (2005-01), the Treatment-IND study, the dose-finding study (99-118), and a controlled randomised prophylaxis study (2004-000592-33). In the Phase 3 pivotal treatment study, the overall incidence of adverse events was similar in the defibrotide treatment group and in the control group (historical). The tabulated list of adverse reactions incorporates the ADRs observed in the safety pooled data set [ADR = any event reported as possibly related on at least two occasions] and TEAEs observed in the final completed Treatment-IND 2006-05 study [TEAE = any AE that started or worsened in severity after the first dose of defibrotide]. For the adverse reactions reported the highest frequency was used in the table below. The safety data from the pivotal study are supported and confirmed with data from the completed Treatment-IND study.
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
Vollständigen Kontext in der EMA-Fachinformation lesen →Quellennachweis
Version 2023-12-20T17:32:00Z · SHA-256 3756d1395580c49e8840b63c6c134ced642c1a0fe4e84f36145b828ae016ed75 · Passage 3ad0a0b5d206027808a08d4645ea3ae7e56a5abe49344364124e6262d0940bd3 · Zeichen 31–1095 im Abschnitt