Comparison · NCT00858364-c2bd4ace
Darbepoetin Alfa vs Placebo: Number of Participants Who Developed Neutralizing Antibodies to Darbepoetin Alfa
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
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ConductScience Library. Darbepoetin Alfa vs Placebo: Number of Participants Who Developed Neutralizing Antibodies to Darbepoetin Alfa. Trial comparisons, record NCT00858364-c2bd4ace. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00858364-c2bd4ace
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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 | 0 | 0.00239 | wilson | |
| Risk in group 2 | 0 | 0 | 0.00476 | wilson | |
| Risk difference, group 1 minus group 2 | 0 | -0.00476 | 0.00239 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | log | a group has no participants with the outcome | |||
| Odds ratio, group 1 over group 2 | log | a cell of the two-by-two table is zero | |||
| Number needed to treat | from the risk difference interval | the two groups' risks are equal |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Darbepoetin Alfa | Participants received darbepoetin alfa 500 µg once every 3 weeks (Q3W) administered subcutaneously until 3 weeks after the completion of chemotherapy or upon determination of disease progression, whichever occurred first. | 0 | 1,606 | OG001 |
| Group 2 | Placebo | Participants received placebo once every 3 weeks (Q3W) administered subcutaneously until 3 weeks after the completion of chemotherapy or upon determination of disease progression, whichever occurred first. | 0 | 803 | OG000 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Participants Who Developed Neutralizing Antibodies to Darbepoetin Alfa
- Description
- Developing antibody incidence was defined as neutralizing antibody positive postbaseline with a negative or no result at baseline.
- Time frame
Baseline and end of the efficacy treatment period (EOETP; defined as 21 days after either the last dose of study drug or the last dose of chemotherapy, whichever was later. the median (range) duration of treatment was 10 (1 to 106) weeks in both groups.
- Population
- Randomized and consented participants who received at least one dose of study drug and with a postbaseline result.
Source ClinicalTrials.gov
Trial
- Title
- Anemia Treatment for Advanced Non-Small Cell Lung Cancer (NSCLC) Patients Receiving Chemotherapy
- NCT number
- NCT00858364
- Phases
- PHASE3
- Conditions
- Non-Small Cell Lung Cancer, Anemia, Cancer, Lung Cancer
- Interventions
- Darbepoetin alfa, Placebo
- Lead sponsor
- Amgen
- Results first posted
- 2018-07-06
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00858364?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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