18 and older, any sex, with Myelodysplastic Syndrome (MDS). Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of Participants With Treatment-emergent Adverse EventsPrimary· From first dose of darbepoetin alfa to 30 days after last dose; the maximum treatment duration was 73 weeks.
Adverse events (AEs) were graded for severity according to the Common Terminology Criteria for Adverse Events (CTCAE), version 4.0, where Grade 1 indicates a mild AE, Grade 2 indicates a moderate AE, Grade 3 indicates severe or medically significant but not immediately life-threatening and Grade 4 indicates life-threatening consequences; urgent intervention indicated.
A serious adverse event was defined as an adverse event that met at least one of the following serious criteria:
* fatal
* life threatening
* required in-patient hospitalization or prolongation of existing hospitalization
* res
All adverse events
Group
Value
95% CI
Darbepoetin Alfa
9
Adverse events ≥ grade 2
Group
Value
95% CI
Darbepoetin Alfa
8
Adverse events ≥ grade 3
Group
Value
95% CI
Darbepoetin Alfa
2
Adverse events ≥ grade 4
Group
Value
95% CI
Darbepoetin Alfa
0
Serious adverse events
Group
Value
95% CI
Darbepoetin Alfa
3
AEs leading to discontinuation of darbepoetin alfa
Group
Value
95% CI
Darbepoetin Alfa
1
Fatal adverse events
Group
Value
95% CI
Darbepoetin Alfa
0
Treatment-related adverse events
Group
Value
95% CI
Darbepoetin Alfa
0
Adverse events — posted to ClinicalTrials.gov
Time frame: From first dose of darbepoetin alfa to 30 days after last dose; the maximum treatment duration was 73 weeks..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
The primary objective of the study was to provide required access of investigational product (darbepoetin alfa) beyond the end of the active treatment period (EOATP) of the darbepoetin alfa MDS 20090160 (NCT01362140) study for patients who had continued demonstration of benefit from darbepoetin alfa treatment and to describe the safety of longer-term use in this patient population.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Amgen
Last refreshed: 14 November 2018
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02175277.