Trial Outcomes & Findings for An Observational, Prospective, Safety Study of Mircera (Monopegylated Epoetin Beta) in Clinical Practice (NCT NCT02263833)

Results Overview

An AE was defined as any untoward medical occurrence in a participant administered with Mircera and which does not necessarily have a causal relationship with Mircera. A Serious Adverse Event (SAE) is any experience that suggests a significant hazard, contraindication, side effect or precaution. It is any AE that at any dose fulfills at least one of the following criteria: is fatal; is life threatening; requires in-patient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is medically significant or requires intervention to prevent one or other of the outcomes listed above.

Recruitment status

COMPLETED

Target enrollment

748 participants

Primary outcome timeframe

At physician's discretion, up to 4 years

Results posted on

2016-09-07

Participant Flow

In total, 748 participants were enrolled from 27 sites, of which only 742 participants were used for safety and efficacy analysis.

Participant milestones

Participant milestones
Measure	Overall Participants Participants not previously on erythropoietin-stimulating agent (ESA) therapy and participants on ESA therapy who were prescribed Mircera either subcutaneously (SC) or intravenously (IV) according to local Korean Mircera label and at physician's discretion were observed as per physician's discretion, approximately up to 4 years.
Overall Study STARTED	742
Overall Study COMPLETED	742
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

An Observational, Prospective, Safety Study of Mircera (Monopegylated Epoetin Beta) in Clinical Practice

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Overall Participants n=742 Participants Participants not previously on ESA therapy and participants on ESA therapy who were prescribed Mircera either SC or IV according to local Korean Mircera label and at physician's discretion were observed as per physician's discretion, approximately up to 4 years.
Age, Continuous	58.7 years STANDARD_DEVIATION 14.2 • n=99 Participants
Sex: Female, Male Female	376 Participants n=99 Participants
Sex: Female, Male Male	366 Participants n=99 Participants

PRIMARY outcome

Timeframe: At physician's discretion, up to 4 years

Population: Safety population included all participants who received at least a dose of Mircera and had the safety assessment at least once.

An AE was defined as any untoward medical occurrence in a participant administered with Mircera and which does not necessarily have a causal relationship with Mircera. A Serious Adverse Event (SAE) is any experience that suggests a significant hazard, contraindication, side effect or precaution. It is any AE that at any dose fulfills at least one of the following criteria: is fatal; is life threatening; requires in-patient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is medically significant or requires intervention to prevent one or other of the outcomes listed above.

Outcome measures

Outcome measures
Measure	Overall Participants n=742 Participants Participants not previously on ESA therapy and participants on ESA therapy who were prescribed Mircera either SC or IV according to local Korean Mircera label and at physician's discretion were observed as per physician's discretion, approximately up to 4 years.
Percentage of Participants With an Adverse Event (AE) and a Serious Adverse Event Adverse event	3 percentage of participants
Percentage of Participants With an Adverse Event (AE) and a Serious Adverse Event Serious adverse event	0.40 percentage of participants

PRIMARY outcome

Timeframe: At physician's discretion, up to 4 years

Population: Safety population included all participants who received at least a dose of Mircera and had the safety assessment at least once.

ADRs were defined as any response to a drug which was noxious and unintended, and which occurred at dose normally used related to the pharmacological properties. It was defined as any AE categorized as "definitely related","probably related", "possibly related", and "unknown" by investigators. In case that an ADR was not written on local Korean Mircera label, it was classified as "Unexpected". An AE was defined as any untoward medical occurrence in a participant administered with Mircera and which does not necessarily have a causal relationship with Mircera.

Outcome measures

Outcome measures
Measure	Overall Participants n=742 Participants Participants not previously on ESA therapy and participants on ESA therapy who were prescribed Mircera either SC or IV according to local Korean Mircera label and at physician's discretion were observed as per physician's discretion, approximately up to 4 years.
Percentage of Participants With an Adverse Drug Reaction (ADR)	2.0 percentage of participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 4 years

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 4 years

Outcome measures

Outcome data not reported

Adverse Events

Overall Participants

Serious events: 3 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Overall Participants n=742 participants at risk Participants not previously on ESA therapy and participants on ESA therapy who were prescribed Mircera either SC or IV according to local Korean Mircera label and at physician's discretion were observed as per physician's discretion, approximately up to 4 years.
Cardiac disorders Atrioventricular block	0.13% 1/742 • Up to 4 years An AE was defined as any untoward medical occurrence in a participant administered with Mircera and which does not necessarily have a causal relationship with Mircera.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.13% 1/742 • Up to 4 years An AE was defined as any untoward medical occurrence in a participant administered with Mircera and which does not necessarily have a causal relationship with Mircera.
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	0.13% 1/742 • Up to 4 years An AE was defined as any untoward medical occurrence in a participant administered with Mircera and which does not necessarily have a causal relationship with Mircera.

Other adverse events

Adverse event data not reported

Additional Information

Medical Communications

Hoffmann-La Roche

Phone: 800-821-8590

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
Publication restrictions are in place

Restriction type: OTHER