An Observational Study of NeoRecormon (Epoetin Beta) in Anemic Patients With Non-myeloid Malignancy

Study Overview
=================
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.

Official Title
-----------------
Multicenter, Observational Study to Evaluate NeoRecormon Treatment in Anemic Patients Suffering From Non-myeloid Malignancy Receiving Chemotherapy

Conditions
-----------------
Anemia

Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cohort<br> | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline to Week 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline, Week 4, Week 8, Week 12, and Week 16 | 
| 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. | Up to Week 16 | 
| 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. | Up to Week 16 | 
| 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. | Up to Week 16 |