Trial · NCT01168349
An Observational Study of NeoRecormon (Epoetin Beta) in Cancer Patients With Anemia (FAST)
NCT01168349, Completed, Hoffmann-La Roche; results first posted 2015-10-02
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. An Observational Study of NeoRecormon (Epoetin Beta) in Cancer Patients With Anemia (FAST). Trials, record NCT01168349. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01168349
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- An Observational Study of NeoRecormon (Epoetin Beta) in Cancer Patients With Anemia (FAST)
- NCT number
- NCT01168349
- Status
- Completed
- Enrollment
- 1,060 participants, actual
- Lead sponsor
- Hoffmann-La Roche
- Conditions
- Anemia, Neoplasms
- Interventions
- epoetin beta [NeoRecormon]
- First posted
- 2010-07-23
- Last updated
- 2015-10-02
- Results first posted
- 2015-10-02
Source ClinicalTrials.gov
Registered outcomes32
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Early Treatment Response: Day 28 to 42 | Day 28 to 42 | Early treatment response was defined as an increase of Hemoglobin (Hb) concentration of at least 1 gram/deciliter (g/dL), 4 to 6 weeks after treatment initiation. |
| Primary | Percentage of Participants With Early Treatment Response: Day 21 to 42 | Day 21 to 42 | Early treatment response was defined as an increase of Hb concentration of at least 1 g/dL, 3 to 6 weeks after treatment initiation. |
| Primary | Percentage of Participants With At Least 1 Red Blood Cell (RBC) Transfusion | Baseline up to Week 28 | Participants with at least 1 RBC transfusion was assessed based on the number of participants with early response or not at Day 21 to 42. Early treatment response was defined as an increase of Hb concentration of at least 1 g/dL, 3 to 6 weeks after treatment initiation. |
| Primary | Mean Number of RBC Transfusions | Baseline up to Week 28 | Mean number of transfusion was based on the number of participants with at least 1 RBC transfusion. |
| Primary | Mean Number of RBC Units | Baseline up to Week 28 | Mean number of units was based on the number of participants with at least 1 RBC transfusion. |
| Primary | Time to First RBC Transfusions | Baseline up to Week 28 | Time to first RBC transfusion was assessed based on the number of participants with early response or not at Day 21 to 42. Early treatment response was defined as an increase of Hb concentration of at least 1 g/dL, 3 to 6 weeks after treatment initiation. Kaplan-Meier estimate was used. |
| Primary | Karnofsky Performance Status (KPS): Baseline | Baseline | KPS was used to quantify participant's general well-being and activities of daily life and participants were classified based on their functional impairment. An 11-level score, KPS score ranged between 0 (death) to 100 (no evidence of disease). Higher score means higher ability to perform daily tasks. KPS was based on the number of participants with early response. |
| Primary | KPS: Week 4 to 6 | Week 4 to 6 | KPS was used to quantify participant's general well-being and activities of daily life and participants were classified based on their functional impairment. An 11-level score, KPS score ranged between 0 (death) to 100 (no evidence of disease). Higher score means higher ability to perform daily tasks. KPS was based on the number of participants with early response. |
| Primary | KPS: Week 12 to 16 | Week 12 to 16 | KPS was used to quantify participant's general well-being and activities of daily life and participants were classified based on their functional impairment. An 11-level score, KPS score ranged between 0 (death) to 100 (no evidence of disease). Higher score means higher ability to perform daily tasks. KPS was based on the number of participants with early response. |
| Primary | KPS: Week 24 to 28 | Week 24 to 28 | KPS was used to quantify participant's general well-being and activities of daily life and participants were classified based on their functional impairment. An 11-level score, KPS score ranged between 0 (death) to 100 (no evidence of disease). Higher score means higher ability to perform daily tasks. KPS was based on the number of participants with early response. |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 registered outcomesOutcomes32
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Early Treatment Response: Day 28 to 42 | Day 28 to 42 | Efficacy population. Here number of participants analyzed included those participants who were evaluable for the outcome measure. | percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With Early Treatment Response: Day 21 to 42 | Day 21 to 42 | Efficacy population. Here number of participants analyzed included those participants who were evaluable for the outcome measure. | percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With At Least 1 Red Blood Cell (RBC) Transfusion | Baseline up to Week 28 | Efficacy population. Here number of participants analyzed included those participants who were evaluable for the outcome measure. | percentage of participants | NUMBER |
| PRIMARY | Mean Number of RBC Transfusions | Baseline up to Week 28 | Efficacy population. Here number of participants analyzed included those participants who were evaluable for the outcome measure without any missing data. | RBC transfusions | MEAN |
| PRIMARY | Mean Number of RBC Units | Baseline up to Week 28 | Efficacy population. Here number of participants analyzed included those participants who were evaluable for the outcome measure without any missing data. | RBC units | MEAN |
| PRIMARY | Time to First RBC Transfusions | Baseline up to Week 28 | Efficacy population. Here number of participants analyzed included those participants who were evaluable for the outcome measure. | weeks | MEDIAN |
| PRIMARY | Karnofsky Performance Status (KPS): Baseline | Baseline | Efficacy population. Here number of participants analyzed included those participants who were evaluable for the outcome measure. | units on a scale | MEAN |
| PRIMARY | KPS: Week 4 to 6 | Week 4 to 6 | Efficacy population. Here number of participants analyzed included those participants who were evaluable for the outcome measure. | units on a scale | MEAN |
| PRIMARY | KPS: Week 12 to 16 | Week 12 to 16 | Efficacy population. Here number of participants analyzed included those participants who were evaluable for the outcome measure. | units on a scale | MEAN |
| PRIMARY | KPS: Week 24 to 28 | Week 24 to 28 | Efficacy population. Here number of participants analyzed included those participants who were evaluable for the outcome measure. | units on a scale | MEAN |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 outcomesResults by group239
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With Early Treatment Response: Day 28 to 42 | Solid Tumor Participants | 52.4 | 95% Confidence Interval 47.48 to 57.23 | percentage of participants | |
| Percentage of Participants With Early Treatment Response: Day 28 to 42 | Hematological Malignancy Participants | 56.5 | 95% Confidence Interval 49.74 to 63.18 | percentage of participants | |
| Percentage of Participants With Early Treatment Response: Day 28 to 42 | Anemic Cancer Participants (Total Participants) | 53.8 | 95% Confidence Interval 49.81 to 57.71 | percentage of participants | |
| Percentage of Participants With Early Treatment Response: Day 21 to 42 | Solid Tumor Participants | 52.4 | 95% Confidence Interval 48.11 to 56.71 | percentage of participants | |
| Percentage of Participants With Early Treatment Response: Day 21 to 42 | Hematological Malignancy Participants | 55.7 | 95% Confidence Interval 49.71 to 61.74 | percentage of participants | |
| Percentage of Participants With Early Treatment Response: Day 21 to 42 | Anemic Cancer Participants (Total Participants) | 53.5 | 95% Confidence Interval 50.02 to 57.02 | percentage of participants | |
| Percentage of Participants With At Least 1 Red Blood Cell (RBC) Transfusion | Responders | 17.2 | percentage of participants | ||
| Percentage of Participants With At Least 1 Red Blood Cell (RBC) Transfusion | Non-responders | 31.4 | percentage of participants | ||
| Percentage of Participants With At Least 1 Red Blood Cell (RBC) Transfusion | Anemic Cancer Participants (Total Participants) | 23.8 | percentage of participants | ||
| Mean Number of RBC Transfusions | Responders | 1.7 | Standard Deviation 1.4 | RBC transfusions |
1 to 10 of 239Source ClinicalTrials.gov
See all 239 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Anemic Cancer Participants (Total Participants) | 1,055 | |
| Overall Study | COMPLETED | Anemic Cancer Participants (Total Participants) | 754 | |
| Overall Study | NOT COMPLETED | Anemic Cancer Participants (Total Participants) | 301 |
Source ClinicalTrials.gov
Adverse events288
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 | Asthenia | General disorders | Solid Tumor Participants | 8 | 8 | 9 |
| other | Asthenia | General disorders | Hematological Malignancy Participants | 3 | 319 | 3 |
| other | Asthenia | General disorders | Anemic Cancer Participants (Total Participants) | 11 | 1,054 | 12 |
| other | Disease progression | General disorders | Solid Tumor Participants | 9 | 735 | 9 |
| other | Disease progression | General disorders | Hematological Malignancy Participants | 1 | 319 | 1 |
| other | Disease progression | General disorders | Anemic Cancer Participants (Total Participants) | 10 | 1,054 | 10 |
| other | General physical health deterioration | General disorders | Solid Tumor Participants | 5 | 735 | 5 |
| other | General physical health deterioration | General disorders | Hematological Malignancy Participants | 1 | 319 | 1 |
| other | General physical health deterioration | General disorders | Anemic Cancer Participants (Total Participants) | 6 | 1,054 | 6 |
| other | Pyrexia | General disorders | Solid Tumor Participants | 2 | 735 | 2 |
1 to 10 of 288Source ClinicalTrials.gov
See all 288 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Solid Tumor Participants | ||
| Total, all-cause mortality | Hematological Malignancy Participants | ||
| Total, all-cause mortality | Anemic Cancer Participants (Total Participants) | ||
| Total, other adverse events | Solid Tumor Participants | 63 | 735 |
| Total, other adverse events | Hematological Malignancy Participants | 31 | 319 |
| Total, other adverse events | Anemic Cancer Participants (Total Participants) | 94 | 1,054 |
| Total, serious adverse events | Solid Tumor Participants | 6 | 735 |
| Total, serious adverse events | Hematological Malignancy Participants | 4 | 319 |
| Total, serious adverse events | Anemic Cancer Participants (Total Participants) | 10 | 1,054 |
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/NCT01168349
GET https://conductscience.org/api/trials/v1/NCT01168349/registered?page=2