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This observational study will evaluate the efficacy and safety of epoetin beta (NeoRecormon) in participants with symptomatic anemia and cancer receiving chemotherapy. Participants receiving NeoRecormon once weekly in accordance with the Summary of Product Characteristics will be followed for 4 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NeoRecormon in Symptomatic Anemia | Participants with symptomatic anemia who are receiving epoetin beta (NeoRecormon) according to standard of care and the Summary of Product Characteristics will be observed for 4 months. Treatment must be selected at the discretion of the prescriber prior to enrollment and will not be chosen by the Sponsor in this non-interventional study. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Epoetin beta | Drug | Treatment will be given according to standard of care and the Summary of Product Characteristics during the study. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in Hemoglobin (Hb) Level From Baseline to End of Treatment (EOT) | 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). | Baseline, Month 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants by Change in Eastern Cooperative Oncology Group (ECOG) Performance Status From Baseline to EOT | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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Participants with symptomatic anemia due to malignancies will be included.
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Budapest | 1031 | Hungary | ||||
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Baseline, Month 4 |
| Percentage of Participants Who Required Blood Transfusions During the Study | 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. | Baseline to Month 1, Month 1 to 2, Month 2 to 3, Month 3 to 4 |
| Budapest |
| 1076 |
| Hungary |
| Budapest | 1082 | Hungary |
| Budapest | 1083 | Hungary |
| Budapest | 1085 | Hungary |
| Budapest | 1088 | Hungary |
| Budapest | 1097 | Hungary |
| Budapest | 1106 | Hungary |
| Budapest | 1122 | Hungary |
| Budapest | 1125 | Hungary |
| Budapest | 1145 | Hungary |
| Budapest | 1529 | Hungary |
| Debrecen | 4012 | Hungary |
| Debrecen | 4032 | Hungary |
| Debrecen | H-4031 | Hungary |
| Deszk | 6772 | Hungary |
| Dunaújváros | 2400 | Hungary |
| Eger | 3300 | Hungary |
| Farkasgyepű | 8582 | Hungary |
| Győr | 9024 | Hungary |
| Gyula | 5700 | Hungary |
| Kaposvár | 7400 | Hungary |
| Kecskemét | 6000 | Hungary |
| Miskolc | 3501 | Hungary |
| Miskolc | 3529 | Hungary |
| Mosdós | 7257 | Hungary |
| NyÃregyháza | 4400 | Hungary |
| Pécs | 7623 | Hungary |
| Pécs | 7624 | Hungary |
| Pécs | 7635 | Hungary |
| Salgótarján | 3100 | Hungary |
| Szeged | 6720 | Hungary |
| Szekszárd | 7100 | Hungary |
| Székesfehérvár | 8000 | Hungary |
| Székesfehérvár | 8001 | Hungary |
| Szolnok | 5004 | Hungary |
| Szolnok | 5007 | Hungary |
| Szombathely | 9700 | Hungary |
| Tatabánya | 2800 | Hungary |
| Törökbálint | 2045 | Hungary |
| Veszprém | 8200 | Hungary |
| Zalaegerszeg | 8900 | Hungary |
| COMPLETED |
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| NOT COMPLETED |
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All Participants Enrolled: All participants who were enrolled into the study regardless of whether treatment was received. Number of participants with available data for age = 1134.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex/Gender, Customized | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Change in Hemoglobin (Hb) Level From Baseline to End of Treatment (EOT) | 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). | All Participants Enrolled; only those who provided data at all study visits were included in the analysis. | Posted | Mean | 95% Confidence Interval | g/L | Baseline, Month 4 |
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| Secondary | Percentage of Participants by Change in Eastern Cooperative Oncology Group (ECOG) Performance Status From Baseline to EOT | 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. | 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. | Posted | Number | percentage of participants | Baseline, Month 4 |
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| Secondary | Percentage of Participants Who Required Blood Transfusions During the Study | 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. | 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. | Posted | Number | percentage of participants | Baseline to Month 1, Month 1 to 2, Month 2 to 3, Month 3 to 4 |
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From Baseline to Month 4
Analysis Population Description: All Participants Enrolled.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 7 | 1,167 | 6 | 1,167 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (19.0) | Non-systematic Assessment |
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| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA (19.0) | Non-systematic Assessment |
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| Granulocytopenia | Blood and lymphatic system disorders | MedDRA (19.0) | Non-systematic Assessment |
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| Pancytopenia | Blood and lymphatic system disorders | MedDRA (19.0) | Non-systematic Assessment |
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| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (19.0) | Non-systematic Assessment |
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| Death | General disorders | MedDRA (19.0) | Non-systematic Assessment |
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| Non-Hodgkin's lymphoman | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.0) | Non-systematic Assessment |
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| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dyspnoea | Cardiac disorders | MedDRA (19.0) | Non-systematic Assessment |
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| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA (19.0) | Non-systematic Assessment |
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| Asthenia | General disorders | MedDRA (19.0) | Non-systematic Assessment |
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| Drug hypersensitivity | Immune system disorders | MedDRA (19.0) | Non-systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA (19.0) | Non-systematic Assessment |
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| Abdominal cavity drainage | Surgical and medical procedures | MedDRA (19.0) | Non-systematic Assessment |
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| Hospitalisation | Surgical and medical procedures | MedDRA (19.0) | Non-systematic Assessment |
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| Transfusion | Surgical and medical procedures | MedDRA (19.0) | Non-systematic Assessment |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffmann-La Roche | 800-821-8590 | genentech@druginfo.com |
| ID | Term |
|---|---|
| D000740 | Anemia |
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| C103998 | epoetin beta |
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| Unknown |
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