Long-term Period: Number of Participants With Death As Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, SAEs Leading to Discontinuation, Adverse Events (AEs), Drug-related AEs, AEs Leading to Discontinuation, and AEs of Interest From Day 169 to Day 729 [clinicaltrials_resource:dd22449d3aa35edc31862d8d83a5776d]
Presp=prespecified; acute= ≤1 hour after start of infusion; periinfusional= ≤24 hours after start of infusion. AE=any new unfavorable symptom or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=an unfavorable medical event that at any dose results in death, significant disability, drug dependency/abuse, hospitalization or prolonged hospitalization; is life-threatening, an important medical event, or a congenital anomaly/birth defect. Drug-related=possibly, probably, or certainly related and of unknown relationship to study drug.
clinicaltrials_vocabulary:primary outcome [clinicaltrials_vocabulary:clinicaltrials_vocabulary:primary-outcome]
Long-term Period: Number of Participants With Death As Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, SAEs Leading to Discontinuation, Adverse Events (AEs), Drug-related AEs, AEs Leading to Discontinuation, and AEs of Interest From Day 169 to Day 729 [clinicaltrials_resource:dd22449d3aa35edc31862d8d83a5776d]
Presp=prespecified; acute= ≤1 hour after start of infusion; periinfusional= ≤24 hours after start of infusion. AE=any new unfavorable symptom or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=an unfavorable medical event that at any dose results in death, significant disability, drug dependency/abuse, hospitalization or prolonged hospitalization; is life-threatening, an important medical event, or a congenital anomaly/birth defect. Drug-related=possibly, probably, or certainly related and of unknown relationship to study drug.
Bio2RDF identifier
dd22449d3aa35edc31862d8d83a5776d
Bio2RDF namespace
clinicaltrials_resource
Bio2RDF uri
http://bio2rdf.org/clinicaltrials_resource:dd22449d3aa35edc31862d8d83a5776d
measure [clinicaltrials_vocabulary:measure]
Long-term Period: Number of Pa ...... tinuation, and AEs of Interest
time frame [clinicaltrials_vocabulary:time-frame]
From Day 169 to Day 729
description
Presp=prespecified; acute= ≤1 ...... wn relationship to study drug.
identifier
clinicaltrials_resource:dd22449d3aa35edc31862d8d83a5776d
title
Long-term Period: Number of Pa ...... erest From Day 169 to Day 729
@en
type
label
Long-term Period: Number of Pa ...... 2449d3aa35edc31862d8d83a5776d]
@en