Trial Outcomes & Findings for An Observational Study of NeoRecormon (Epoetin Beta) in Anemic Patients With Non-myeloid Malignancy (NCT NCT01716559)
NCT ID: NCT01716559
Last Updated: 2016-08-18
Results Overview
Therapeutic response was defined as an increase of greater than or equal to (\>=) 1 gram per decilitre (g/dL) in hemoglobin (Hb) level as compared to baseline, following 8 weeks of Epoetin beta treatment. The Therapeutic response rate was summarized as percentage of participants with an increase of \>= 1 g/dL in Hb level at Week 8 as compared to baseline.
Recruitment status
COMPLETED
Target enrollment
160 participants
Primary outcome timeframe
Baseline to Week 8
Results posted on
2016-08-18
Participant Flow
This is an observational study. A total of 160 participants were enrolled across 8 study centers in Hungary from 03 August 2010 to 28 March 2012.
Participant milestones
| Measure |
Epoetin Beta
Participants receiving 30,000 International units (IU) of Epoetin beta (NeoRecormon) subcutaneously by prefilled pen injection once a week for 16 weeks were observed.
|
|---|---|
|
Overall Study
STARTED
|
160
|
|
Overall Study
COMPLETED
|
49
|
|
Overall Study
NOT COMPLETED
|
111
|
Reasons for withdrawal
| Measure |
Epoetin Beta
Participants receiving 30,000 International units (IU) of Epoetin beta (NeoRecormon) subcutaneously by prefilled pen injection once a week for 16 weeks were observed.
|
|---|---|
|
Overall Study
Adverse Event
|
11
|
|
Overall Study
Death
|
21
|
|
Overall Study
Withdrawal by Subject
|
4
|
|
Overall Study
Other withdrawal reason
|
75
|
Baseline Characteristics
An Observational Study of NeoRecormon (Epoetin Beta) in Anemic Patients With Non-myeloid Malignancy
Baseline characteristics by cohort
| Measure |
Epoetin Beta
n=160 Participants
Participants receiving 30,000 International units (IU) of Epoetin beta subcutaneously by prefilled pen injection once a week for 16 weeks were observed.
|
|---|---|
|
Age, Continuous
|
63 years
STANDARD_DEVIATION 9.97 • n=5 Participants
|
|
Sex: Female, Male
Female
|
87 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
73 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to Week 8Population: The analysis was performed on total population. At the end of the Week 8, data allowing the evaluation of the therapeutic response was available for 103 participants out of total population of 160.
Therapeutic response was defined as an increase of greater than or equal to (\>=) 1 gram per decilitre (g/dL) in hemoglobin (Hb) level as compared to baseline, following 8 weeks of Epoetin beta treatment. The Therapeutic response rate was summarized as percentage of participants with an increase of \>= 1 g/dL in Hb level at Week 8 as compared to baseline.
Outcome measures
| Measure |
Epoetin Beta
n=103 Participants
Participants receiving 30,000 International units (IU) of Epoetin beta subcutaneously by prefilled pen injection once a week for 16 weeks were observed.
|
|---|---|
|
Percentage of Participants With an Increase of Greater Than or Equal to 1 Gram Per Decilitre in Hemoglobin Level at Week 8
|
67.96 percentage of participants
Interval 58.95 to 76.97
|
SECONDARY outcome
Timeframe: Baseline, Week 4, Week 8, Week 12, and Week 16Population: The analysis was performed on Total population. The "n" signifies the number of participants assessed for mean change in hemoglobin level for specified time point.
The mean change in Hb concentration was calculated by subtracting the baseline Hb concentration from the Weekly Hb concentration.
Outcome measures
| Measure |
Epoetin Beta
n=160 Participants
Participants receiving 30,000 International units (IU) of Epoetin beta subcutaneously by prefilled pen injection once a week for 16 weeks were observed.
|
|---|---|
|
Mean Change From Baseline in Hemoglobin Level up to Week 16
Week 4; n = 149
|
1.194 g/dL
Standard Error 0.133
|
|
Mean Change From Baseline in Hemoglobin Level up to Week 16
Week 8, n = 103
|
1.641 g/dL
Standard Error 0.169
|
|
Mean Change From Baseline in Hemoglobin Level up to Week 16
Week 12, n = 70
|
1.970 g/dL
Standard Error 0.198
|
|
Mean Change From Baseline in Hemoglobin Level up to Week 16
Week 16, n = 50
|
1.789 g/dL
Standard Error 0.227
|
SECONDARY outcome
Timeframe: Up to Week 16Population: The analysis was performed on Total population.
Percentage of participants who have not received red blood cell (RBC) transfusion (packed RBC or whole blood) during the study were reported.
Outcome measures
| Measure |
Epoetin Beta
n=160 Participants
Participants receiving 30,000 International units (IU) of Epoetin beta subcutaneously by prefilled pen injection once a week for 16 weeks were observed.
|
|---|---|
|
Percentage of Red Blood Cell Transfusion-free Participants
|
76.25 percentage of participants
Interval 69.66 to 82.84
|
SECONDARY outcome
Timeframe: Up to Week 16Population: The analysis was performed on total population. At the end of the study, data allowing the evaluation of effect of individual iron supplementation on the efficacy of Epoetin beta treatment were available for 103 participants out of total population of 160.
Effect of individual iron supplementation on the efficacy of Epoetin beta treatment was described by percentage of participants with or with no response on efficacy of treatment due iron replacement therapy. Response was determined by calculating the difference in Hb level at H3 (Week 8) as compared to H1 (baseline). If H3-H1 is greater than (\>) 1, there is a response (response value =1), otherwise there was no response (response value=0). If both were missing, then response was also missing. Response value as "1" denotes an effect on the response of treatment with or without iron replacement therapy. Response value as "0" denotes no effect on the response of treatment with or without iron replacement therapy.
Outcome measures
| Measure |
Epoetin Beta
n=103 Participants
Participants receiving 30,000 International units (IU) of Epoetin beta subcutaneously by prefilled pen injection once a week for 16 weeks were observed.
|
|---|---|
|
Number of Participants With or With no Response on Efficacy of Treatment With or Without Iron Replacement Therapy
With IRT, Response value = 1
|
44 participants
|
|
Number of Participants With or With no Response on Efficacy of Treatment With or Without Iron Replacement Therapy
Without IRT, Response value = 0
|
9 participants
|
|
Number of Participants With or With no Response on Efficacy of Treatment With or Without Iron Replacement Therapy
Without IRT, Response value = 1
|
31 participants
|
|
Number of Participants With or With no Response on Efficacy of Treatment With or Without Iron Replacement Therapy
With IRT, Response value = 0
|
19 participants
|
SECONDARY outcome
Timeframe: Up to Week 16Population: The analysis was performed on total population.
An adverse event (AE) was defined as any untoward medical occurrence in a subject who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. An AE, therefore, could be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the study treatment, whether or not related to the treatment. A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect. Number of participants with at least one AE and SAE were reported.
Outcome measures
| Measure |
Epoetin Beta
n=160 Participants
Participants receiving 30,000 International units (IU) of Epoetin beta subcutaneously by prefilled pen injection once a week for 16 weeks were observed.
|
|---|---|
|
Number of Participants With Adverse Events and Serious Adverse Events
Any AE
|
43 participants
|
|
Number of Participants With Adverse Events and Serious Adverse Events
Any SAE
|
25 participants
|
Adverse Events
Epoetin Beta
Serious events: 25 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Epoetin Beta
n=160 participants at risk
Participants receiving 30,000 International units (IU) of Epoetin beta subcutaneously by prefilled pen injection once a week for 16 weeks were observed.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia haemolytic autoimmune
|
0.62%
1/160 • Up to Week 16
An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
|
|
Blood and lymphatic system disorders
Bone marrow failure
|
1.2%
2/160 • Up to Week 16
An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.62%
1/160 • Up to Week 16
An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
|
|
Blood and lymphatic system disorders
Granulocytopenia
|
0.62%
1/160 • Up to Week 16
An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
|
|
Blood and lymphatic system disorders
Idiopathic thrombocytopenic purpura
|
0.62%
1/160 • Up to Week 16
An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.62%
1/160 • Up to Week 16
An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.62%
1/160 • Up to Week 16
An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
|
|
Cardiac disorders
Cardiopulmonary failure
|
1.9%
3/160 • Up to Week 16
An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
|
|
Cardiac disorders
Myocardial infarction
|
0.62%
1/160 • Up to Week 16
An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
|
|
Gastrointestinal disorders
Nausea
|
0.62%
1/160 • Up to Week 16
An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
|
|
General disorders
Asthenia
|
0.62%
1/160 • Up to Week 16
An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
|
|
General disorders
Disease progression
|
5.6%
9/160 • Up to Week 16
An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
|
|
General disorders
Fatigue
|
0.62%
1/160 • Up to Week 16
An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
|
|
General disorders
General physical health deterioration
|
1.2%
2/160 • Up to Week 16
An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.62%
1/160 • Up to Week 16
An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
|
|
Infections and infestations
Brain abscess
|
0.62%
1/160 • Up to Week 16
An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
|
|
Infections and infestations
Diverticulitis
|
0.62%
1/160 • Up to Week 16
An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
|
|
Infections and infestations
Herpes zoster
|
0.62%
1/160 • Up to Week 16
An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
|
|
Infections and infestations
Pneumonia
|
0.62%
1/160 • Up to Week 16
An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
|
|
Infections and infestations
Sepsis
|
0.62%
1/160 • Up to Week 16
An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.62%
1/160 • Up to Week 16
An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.62%
1/160 • Up to Week 16
An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Plasma cell myeloma
|
0.62%
1/160 • Up to Week 16
An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
|
|
Nervous system disorders
Hemiparesis
|
0.62%
1/160 • Up to Week 16
An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
|
|
Renal and urinary disorders
Renal failure
|
0.62%
1/160 • Up to Week 16
An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.62%
1/160 • Up to Week 16
An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.9%
3/160 • Up to Week 16
An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.62%
1/160 • Up to Week 16
An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.62%
1/160 • Up to Week 16
An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory arrest
|
0.62%
1/160 • Up to Week 16
An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.62%
1/160 • Up to Week 16
An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
|
|
Vascular disorders
Circulatory collapse
|
0.62%
1/160 • Up to Week 16
An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
|
|
Vascular disorders
Shock
|
0.62%
1/160 • Up to Week 16
An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
|
Other adverse events
| Measure |
Epoetin Beta
n=160 participants at risk
Participants receiving 30,000 International units (IU) of Epoetin beta subcutaneously by prefilled pen injection once a week for 16 weeks were observed.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
1.2%
2/160 • Up to Week 16
An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
|
|
Blood and lymphatic system disorders
Granulocytopenia
|
1.9%
3/160 • Up to Week 16
An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
|
|
Blood and lymphatic system disorders
Granulocytosis
|
0.62%
1/160 • Up to Week 16
An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.62%
1/160 • Up to Week 16
An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
1.2%
2/160 • Up to Week 16
An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastasis to Bone
|
0.62%
1/160 • Up to Week 16
An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.62%
1/160 • Up to Week 16
An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
0.62%
1/160 • Up to Week 16
An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.62%
1/160 • Up to Week 16
An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
|
Additional Information
Roche Trial Information Hotline
F. Hoffmann-La Roche AG
Phone: +41 61 6878333
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