Trial Outcomes & Findings for An Observational Study of Epoetin Beta (NeoRecormon) in Participants With Cancer Receiving Chemotherapy (NCT NCT01809314)
NCT ID: NCT01809314
Last Updated: 2016-08-19
Results Overview
The change in Hb level from Baseline to the EOT visit at Month 4 was averaged among all participants and expressed in grams per liter (g/L).
COMPLETED
1167 participants
Baseline, Month 4
2016-08-19
Participant Flow
Participant milestones
| Measure |
NeoRecormon in Symptomatic Anemia
Participants with symptomatic anemia who received epoetin beta (NeoRecormon) according to standard of care and the Summary of Product Characteristics were observed for 4 months. Treatment was selected at the discretion of the prescriber prior to enrollment and not chosen by the Sponsor in this non-interventional study.
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|---|---|
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Overall Study
STARTED
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1167
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Overall Study
COMPLETED
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422
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Overall Study
NOT COMPLETED
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745
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Reasons for withdrawal
| Measure |
NeoRecormon in Symptomatic Anemia
Participants with symptomatic anemia who received epoetin beta (NeoRecormon) according to standard of care and the Summary of Product Characteristics were observed for 4 months. Treatment was selected at the discretion of the prescriber prior to enrollment and not chosen by the Sponsor in this non-interventional study.
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|---|---|
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Overall Study
Withdrawal Prior to Treatment
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1
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Overall Study
Adverse Event
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6
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Overall Study
Insufficient Therapeutic Response
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14
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Overall Study
Lost to Follow-up
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724
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Baseline Characteristics
An Observational Study of Epoetin Beta (NeoRecormon) in Participants With Cancer Receiving Chemotherapy
Baseline characteristics by cohort
| Measure |
NeoRecormon in Symptomatic Anemia
n=1167 Participants
Participants with symptomatic anemia who received epoetin beta (NeoRecormon) according to standard of care and the Summary of Product Characteristics were observed for 4 months. Treatment was selected at the discretion of the prescriber prior to enrollment and not chosen by the Sponsor in this non-interventional study.
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|---|---|
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Age, Continuous
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60.8 years
STANDARD_DEVIATION 13.0 • n=5 Participants
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Sex/Gender, Customized
Male
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398 participants
n=5 Participants
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Sex/Gender, Customized
Female
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709 participants
n=5 Participants
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Sex/Gender, Customized
Unknown
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60 participants
n=5 Participants
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PRIMARY outcome
Timeframe: Baseline, Month 4Population: All Participants Enrolled; only those who provided data at all study visits were included in the analysis.
The change in Hb level from Baseline to the EOT visit at Month 4 was averaged among all participants and expressed in grams per liter (g/L).
Outcome measures
| Measure |
NeoRecormon in Symptomatic Anemia
n=280 Participants
Participants with symptomatic anemia who received epoetin beta (NeoRecormon) according to standard of care and the Summary of Product Characteristics were observed for 4 months. Treatment was selected at the discretion of the prescriber prior to enrollment and not chosen by the Sponsor in this non-interventional study.
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Change in Hemoglobin (Hb) Level From Baseline to End of Treatment (EOT)
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14.58 g/L
Interval 12.684 to 16.478
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SECONDARY outcome
Timeframe: Baseline, Month 4Population: All Participants Enrolled; only those who provided data at all study visits were included in the analysis. The "Number of Participants Analyzed" reflects the total combined number of participants who provided data for the endpoint. The number of participants used in the denominator for each calculation (n) was based on the ECOG status at Baseline.
ECOG performance status was determined at Baseline and at the EOT visit at Month 4. The assessment used a 3-point scale, including scores of 0 (fully active/able to carry on all pre-disease activities without restriction), 1 (restricted in physically strenuous activity but ambulatory/able to carry out light or sedentary work), or 2 (ambulatory for more than 50% of waking hours and capable of all self care but unable to carry out any work activities). The traditional 6-point scale was not valid because only participants with a performance status of 0, 1, or 2 were eligible for the study. The percentage of participants by change in ECOG performance status was reported. For example, the percentage of participants with ECOG performance status of 0 at Baseline and 2 at EOT is shown in the table as "Baseline 0, EOT 2". Transition to a lower performance status indicates improved/increased independence.
Outcome measures
| Measure |
NeoRecormon in Symptomatic Anemia
n=272 Participants
Participants with symptomatic anemia who received epoetin beta (NeoRecormon) according to standard of care and the Summary of Product Characteristics were observed for 4 months. Treatment was selected at the discretion of the prescriber prior to enrollment and not chosen by the Sponsor in this non-interventional study.
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|---|---|
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Percentage of Participants by Change in Eastern Cooperative Oncology Group (ECOG) Performance Status From Baseline to EOT
Baseline 0, EOT 0 (n=71)
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77.5 percentage of participants
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Percentage of Participants by Change in Eastern Cooperative Oncology Group (ECOG) Performance Status From Baseline to EOT
Baseline 0, EOT 1 (n=71)
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19.7 percentage of participants
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Percentage of Participants by Change in Eastern Cooperative Oncology Group (ECOG) Performance Status From Baseline to EOT
Baseline 0, EOT 2 (n=71)
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2.8 percentage of participants
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Percentage of Participants by Change in Eastern Cooperative Oncology Group (ECOG) Performance Status From Baseline to EOT
Baseline 1, EOT 0 (n=168)
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23.8 percentage of participants
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Percentage of Participants by Change in Eastern Cooperative Oncology Group (ECOG) Performance Status From Baseline to EOT
Baseline 1, EOT 1 (n=168)
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67.3 percentage of participants
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Percentage of Participants by Change in Eastern Cooperative Oncology Group (ECOG) Performance Status From Baseline to EOT
Baseline 1, EOT 2 (n=168)
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8.9 percentage of participants
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Percentage of Participants by Change in Eastern Cooperative Oncology Group (ECOG) Performance Status From Baseline to EOT
Baseline 2, EOT 0 (n=33)
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21.2 percentage of participants
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Percentage of Participants by Change in Eastern Cooperative Oncology Group (ECOG) Performance Status From Baseline to EOT
Baseline 2, EOT 1 (n=33)
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48.5 percentage of participants
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Percentage of Participants by Change in Eastern Cooperative Oncology Group (ECOG) Performance Status From Baseline to EOT
Baseline 2, EOT 2 (n=33)
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30.3 percentage of participants
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SECONDARY outcome
Timeframe: Baseline to Month 1, Month 1 to 2, Month 2 to 3, Month 3 to 4Population: All Participants Enrolled. The "Number of Participants Analyzed" reflects the total combined number of participants who provided data for the endpoint. The number of participants who provided data for the analysis at each timepoint (n) is shown in the table.
The percentage of participants who required blood transfusions was reported at each assessment visit and was based on the 1-month period preceding the respective visit.
Outcome measures
| Measure |
NeoRecormon in Symptomatic Anemia
n=1073 Participants
Participants with symptomatic anemia who received epoetin beta (NeoRecormon) according to standard of care and the Summary of Product Characteristics were observed for 4 months. Treatment was selected at the discretion of the prescriber prior to enrollment and not chosen by the Sponsor in this non-interventional study.
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Percentage of Participants Who Required Blood Transfusions During the Study
Baseline to Month 1 (n=1073)
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4.1 percentage of participants
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Percentage of Participants Who Required Blood Transfusions During the Study
Month 1 to 2 (n=853)
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4.1 percentage of participants
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Percentage of Participants Who Required Blood Transfusions During the Study
Month 2 to 3 (n=650)
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3.8 percentage of participants
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Percentage of Participants Who Required Blood Transfusions During the Study
Month 3 to 4 (n=281)
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3.9 percentage of participants
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Adverse Events
NeoRecormon in Symptomatic Anemia
Serious adverse events
| Measure |
NeoRecormon in Symptomatic Anemia
n=1167 participants at risk
Participants with symptomatic anemia who received epoetin beta (NeoRecormon) according to standard of care and the Summary of Product Characteristics were observed for 4 months. Treatment was selected at the discretion of the prescriber prior to enrollment and not chosen by the Sponsor in this non-interventional study.
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Blood and lymphatic system disorders
Anaemia
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0.09%
1/1167 • From Baseline to Month 4
Analysis Population Description: All Participants Enrolled.
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Blood and lymphatic system disorders
Febrile neutropenia
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0.09%
1/1167 • From Baseline to Month 4
Analysis Population Description: All Participants Enrolled.
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Blood and lymphatic system disorders
Granulocytopenia
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0.09%
1/1167 • From Baseline to Month 4
Analysis Population Description: All Participants Enrolled.
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Blood and lymphatic system disorders
Pancytopenia
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0.09%
1/1167 • From Baseline to Month 4
Analysis Population Description: All Participants Enrolled.
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Blood and lymphatic system disorders
Thrombocytopenia
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0.09%
1/1167 • From Baseline to Month 4
Analysis Population Description: All Participants Enrolled.
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General disorders
Death
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0.26%
3/1167 • From Baseline to Month 4
Analysis Population Description: All Participants Enrolled.
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Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-Hodgkin's lymphoman
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0.09%
1/1167 • From Baseline to Month 4
Analysis Population Description: All Participants Enrolled.
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Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
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0.09%
1/1167 • From Baseline to Month 4
Analysis Population Description: All Participants Enrolled.
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Other adverse events
| Measure |
NeoRecormon in Symptomatic Anemia
n=1167 participants at risk
Participants with symptomatic anemia who received epoetin beta (NeoRecormon) according to standard of care and the Summary of Product Characteristics were observed for 4 months. Treatment was selected at the discretion of the prescriber prior to enrollment and not chosen by the Sponsor in this non-interventional study.
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|---|---|
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Cardiac disorders
Dyspnoea
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0.09%
1/1167 • From Baseline to Month 4
Analysis Population Description: All Participants Enrolled.
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Gastrointestinal disorders
Gastrooesophageal reflux disease
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0.09%
1/1167 • From Baseline to Month 4
Analysis Population Description: All Participants Enrolled.
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General disorders
Asthenia
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0.09%
1/1167 • From Baseline to Month 4
Analysis Population Description: All Participants Enrolled.
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Immune system disorders
Drug hypersensitivity
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0.09%
1/1167 • From Baseline to Month 4
Analysis Population Description: All Participants Enrolled.
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Infections and infestations
Pneumonia
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0.09%
1/1167 • From Baseline to Month 4
Analysis Population Description: All Participants Enrolled.
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Surgical and medical procedures
Abdominal cavity drainage
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0.09%
1/1167 • From Baseline to Month 4
Analysis Population Description: All Participants Enrolled.
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Surgical and medical procedures
Hospitalisation
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0.09%
1/1167 • From Baseline to Month 4
Analysis Population Description: All Participants Enrolled.
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Surgical and medical procedures
Transfusion
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0.17%
2/1167 • From Baseline to Month 4
Analysis Population Description: All Participants Enrolled.
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Additional Information
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