Comparison · NCT01459653-df47e784
EP2006: Any Grade 4 CIN/FN vs EP2006: No Grade 4 CIN/FN: Number of Participants With All-cause Mortality by Any/no Grade 4 CIN and/or FN
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. EP2006: Any Grade 4 CIN/FN vs EP2006: No Grade 4 CIN/FN: Number of Participants With All-cause Mortality by Any/no Grade 4 CIN and/or FN. Trial comparisons, record NCT01459653-df47e784. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01459653-df47e784
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.0452 | 0.0248 | 0.0813 | wilson | |
| Risk in group 2 | 0.0375 | 0.0282 | 0.0497 | wilson | |
| Risk difference, group 1 minus group 2 | 0.00773 | -0.0161 | 0.0449 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.21 | 0.618 | 2.35 | log | |
| Odds ratio, group 1 over group 2 | 1.22 | 0.604 | 2.45 | log | |
| Number needed to treat, for one more participant with the outcome on EP2006: Any Grade 4 CIN/FN than on EP2006: No Grade 4 CIN/FN | 129 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | EP2006: Any Grade 4 CIN/FN | Cancer patients with any grade 4 CIN/FIN treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN. | 10 | 221 | OG000 |
| Group 2 | EP2006: No Grade 4 CIN/FN | Cancer patients with no grade 4 CIN/FIN treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN. | 46 | 1,226 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Number of Participants With All-cause Mortality by Any/no Grade 4 CIN and/or FN
- Description
Objective 5: To describe the distribution of chemotherapy dose delays and reductions, surgery delays and cancellations, radiotherapy delays, dose reductions, and cancellations, and mortality (GCSF-related; FN-related; cancer-related; not related to GCSF, FN, or cancer; all-cause); and estimate the time-to-event for such events over the course of EP2006 treatment.~Table shows number of patients that died in each group.~CIN: chemotherapy-induced neutropenia; FN: febrile neutropenia
- Time frame
All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days
- Population
- Evaluable sample by any/no grade 4 CIN/FN
Source ClinicalTrials.gov
Trial
- Title
- Multi-level Evaluation of Chemotherapy-induced Febrile Neutropenia Prophylaxis, Outcomes, and Determinants With Granulocyte-colony Stimulating Factor
- NCT number
- NCT01459653
- Phases
- Conditions
- Febrile Neutropenia, Cancer, Breast Cancer, Ovarian Cancer, Lung Cancer, Prostate Cancer, Multiple Myeloma, Bladder Cancer, B-cell Lymphoma
- Interventions
- Lead sponsor
- Sandoz
- Results first posted
- 2015-07-07
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01459653?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
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
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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