Anemia
Conditions
Brief summary
This observational, prospective, multicenter study will evaluate the treatment response rate and the safety of NeoRecormon (epoetin beta) in anemic patients with non-myeloid malignancy. In addition to NeoRecormon, patients receive chemotherapy for their malignancy. Data will be collected for 16 weeks.
Interventions
None listed
Sponsors
Hoffmann-La Roche
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult patients, \>/=18 years of age * Presence of solid-tumor or non-myeloid malignancy * Patients receiving chemotherapy * Eastern Cooperative Oncology Group (ECOG) Performance status 0-2 * Patients require NeoRecormon
Exclusion criteria
* Hypersensitivity to the drug * Uncontrolled hypertension * Female patients if pregnant and/or lactating
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With an Increase of Greater Than or Equal to 1 Gram Per Decilitre in Hemoglobin Level at Week 8 | Baseline to Week 8 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline in Hemoglobin Level up to Week 16 | Baseline, Week 4, Week 8, Week 12, and Week 16 | The mean change in Hb concentration was calculated by subtracting the baseline Hb concentration from the Weekly Hb concentration. |
| Percentage of Red Blood Cell Transfusion-free Participants | Up to Week 16 | Percentage of participants who have not received red blood cell (RBC) transfusion (packed RBC or whole blood) during the study were reported. |
| Number of Participants With or With no Response on Efficacy of Treatment With or Without Iron Replacement Therapy | Up to Week 16 | 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. |
| Number of Participants With Adverse Events and Serious Adverse Events | Up to Week 16 | 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. |
Countries
Hungary
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Epoetin Beta Participants receiving 30,000 International units (IU) of Epoetin beta subcutaneously by prefilled pen injection once a week for 16 weeks were observed. | 160 |
| Total | 160 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 11 |
| Overall Study | Death | 21 |
| Overall Study | Other withdrawal reason | 75 |
| Overall Study | Withdrawal by Subject | 4 |
Baseline characteristics
| Characteristic | Epoetin Beta |
|---|---|
| Age, Continuous | 63 years STANDARD_DEVIATION 9.97 |
| Sex: Female, Male Female | 87 Participants |
| Sex: Female, Male Male | 73 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 11 / 160 |
| serious Total, serious adverse events | 25 / 160 |
Outcome results
Primary
Percentage of Participants With an Increase of Greater Than or Equal to 1 Gram Per Decilitre in Hemoglobin Level at Week 8
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.
Time frame: Baseline to Week 8
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Epoetin Beta | 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 |
Secondary
Mean Change From Baseline in Hemoglobin Level up to Week 16
The mean change in Hb concentration was calculated by subtracting the baseline Hb concentration from the Weekly Hb concentration.
Time frame: Baseline, Week 4, Week 8, Week 12, and Week 16
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Epoetin Beta | Mean Change From Baseline in Hemoglobin Level up to Week 16 | Week 4; n = 149 | 1.194 g/dL | Standard Error 0.133 |
| Epoetin Beta | Mean Change From Baseline in Hemoglobin Level up to Week 16 | Week 8, n = 103 | 1.641 g/dL | Standard Error 0.169 |
| Epoetin Beta | Mean Change From Baseline in Hemoglobin Level up to Week 16 | Week 12, n = 70 | 1.970 g/dL | Standard Error 0.198 |
| Epoetin Beta | Mean Change From Baseline in Hemoglobin Level up to Week 16 | Week 16, n = 50 | 1.789 g/dL | Standard Error 0.227 |
Secondary
Number of Participants With Adverse Events and Serious Adverse Events
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.
Time frame: Up to Week 16
Population: The analysis was performed on total population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Epoetin Beta | Number of Participants With Adverse Events and Serious Adverse Events | Any AE | 43 participants |
| Epoetin Beta | Number of Participants With Adverse Events and Serious Adverse Events | Any SAE | 25 participants |
Secondary
Number of Participants With or With no Response on Efficacy of Treatment With or Without Iron Replacement Therapy
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.
Time frame: Up to Week 16
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Epoetin Beta | 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 |
| Epoetin Beta | 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 |
| Epoetin Beta | 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 |
| Epoetin Beta | 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 |
Secondary
Percentage of Red Blood Cell Transfusion-free Participants
Percentage of participants who have not received red blood cell (RBC) transfusion (packed RBC or whole blood) during the study were reported.
Time frame: Up to Week 16
Population: The analysis was performed on Total population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Epoetin Beta | Percentage of Red Blood Cell Transfusion-free Participants | 76.25 percentage of participants |