Trial · NCT01809314
An Observational Study of Epoetin Beta (NeoRecormon) in Participants With Cancer Receiving Chemotherapy
NCT01809314, Completed, Hoffmann-La Roche; results first posted 2016-08-19
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. An Observational Study of Epoetin Beta (NeoRecormon) in Participants With Cancer Receiving Chemotherapy. Trials, record NCT01809314. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01809314
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- An Observational Study of Epoetin Beta (NeoRecormon) in Participants With Cancer Receiving Chemotherapy
- NCT number
- NCT01809314
- Status
- Completed
- Enrollment
- 1,167 participants, actual
- Lead sponsor
- Hoffmann-La Roche
- Conditions
- Anemia
- Interventions
- Epoetin beta
- First posted
- 2013-03-12
- Last updated
- 2016-08-19
- Results first posted
- 2016-08-19
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Hemoglobin (Hb) Level From Baseline to End of Treatment (EOT) | Baseline, Month 4 | 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). |
| Secondary | Percentage of Participants by Change in Eastern Cooperative Oncology Group (ECOG) Performance Status From Baseline to EOT | Baseline, Month 4 | 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. |
| Secondary | Percentage of Participants Who Required Blood Transfusions During the Study | Baseline to Month 1, Month 1 to 2, Month 2 to 3, Month 3 to 4 | 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. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Hemoglobin (Hb) Level From Baseline to End of Treatment (EOT) | Baseline, Month 4 | All Participants Enrolled; only those who provided data at all study visits were included in the analysis. | g/L | MEAN |
| SECONDARY | Percentage of Participants by Change in Eastern Cooperative Oncology Group (ECOG) Performance Status From Baseline to EOT | Baseline, Month 4 | 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. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Required Blood Transfusions During the Study | Baseline to Month 1, Month 1 to 2, Month 2 to 3, Month 3 to 4 | 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. | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group14
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Hemoglobin (Hb) Level From Baseline to End of Treatment (EOT) | NeoRecormon in Symptomatic Anemia | 14.58 | 95% Confidence Interval 12.684 to 16.478 | g/L | |
| Percentage of Participants by Change in Eastern Cooperative Oncology Group (ECOG) Performance Status From Baseline to EOT | NeoRecormon in Symptomatic Anemia | Baseline 0, EOT 0 (n=71) | 77.5 | percentage of participants | |
| Percentage of Participants by Change in Eastern Cooperative Oncology Group (ECOG) Performance Status From Baseline to EOT | NeoRecormon in Symptomatic Anemia | Baseline 0, EOT 1 (n=71) | 19.7 | percentage of participants | |
| Percentage of Participants by Change in Eastern Cooperative Oncology Group (ECOG) Performance Status From Baseline to EOT | NeoRecormon in Symptomatic Anemia | Baseline 0, EOT 2 (n=71) | 2.8 | percentage of participants | |
| Percentage of Participants by Change in Eastern Cooperative Oncology Group (ECOG) Performance Status From Baseline to EOT | NeoRecormon in Symptomatic Anemia | Baseline 1, EOT 0 (n=168) | 23.8 | percentage of participants | |
| Percentage of Participants by Change in Eastern Cooperative Oncology Group (ECOG) Performance Status From Baseline to EOT | NeoRecormon in Symptomatic Anemia | Baseline 1, EOT 1 (n=168) | 67.3 | percentage of participants | |
| Percentage of Participants by Change in Eastern Cooperative Oncology Group (ECOG) Performance Status From Baseline to EOT | NeoRecormon in Symptomatic Anemia | Baseline 1, EOT 2 (n=168) | 8.9 | percentage of participants | |
| Percentage of Participants by Change in Eastern Cooperative Oncology Group (ECOG) Performance Status From Baseline to EOT | NeoRecormon in Symptomatic Anemia | Baseline 2, EOT 0 (n=33) | 21.2 | percentage of participants | |
| Percentage of Participants by Change in Eastern Cooperative Oncology Group (ECOG) Performance Status From Baseline to EOT | NeoRecormon in Symptomatic Anemia | Baseline 2, EOT 1 (n=33) | 48.5 | percentage of participants | |
| Percentage of Participants by Change in Eastern Cooperative Oncology Group (ECOG) Performance Status From Baseline to EOT | NeoRecormon in Symptomatic Anemia | Baseline 2, EOT 2 (n=33) | 30.3 | percentage of participants |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | NeoRecormon in Symptomatic Anemia | 1,167 | |
| Overall Study | COMPLETED | NeoRecormon in Symptomatic Anemia | 422 | |
| Overall Study | NOT COMPLETED | NeoRecormon in Symptomatic Anemia | 745 |
Source ClinicalTrials.gov
Adverse events16
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Dyspnoea | Cardiac disorders | NeoRecormon in Symptomatic Anemia | 1 | 1,167 | |
| other | Gastrooesophageal reflux disease | Gastrointestinal disorders | NeoRecormon in Symptomatic Anemia | 1 | 1,167 | |
| other | Asthenia | General disorders | NeoRecormon in Symptomatic Anemia | 1 | 1,167 | |
| other | Drug hypersensitivity | Immune system disorders | NeoRecormon in Symptomatic Anemia | 1 | 1,167 | |
| other | Pneumonia | Infections and infestations | NeoRecormon in Symptomatic Anemia | 1 | 1,167 | |
| other | Abdominal cavity drainage | Surgical and medical procedures | NeoRecormon in Symptomatic Anemia | 1 | 1,167 | |
| other | Hospitalisation | Surgical and medical procedures | NeoRecormon in Symptomatic Anemia | 1 | 1,167 | |
| other | Transfusion | Surgical and medical procedures | NeoRecormon in Symptomatic Anemia | 2 | 1,167 | |
| serious | Anaemia | Blood and lymphatic system disorders | NeoRecormon in Symptomatic Anemia | 1 | 1,167 | |
| serious | Febrile neutropenia | Blood and lymphatic system disorders | NeoRecormon in Symptomatic Anemia | 1 | 1,167 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | NeoRecormon in Symptomatic Anemia | ||
| Total, other adverse events | NeoRecormon in Symptomatic Anemia | 6 | 1,167 |
| Total, serious adverse events | NeoRecormon in Symptomatic Anemia | 7 | 1,167 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01809314
GET https://conductscience.org/api/trials/v1/NCT01809314/registered