Comparison · NCT00464204-sae
Voluven® Arm vs NaCl 0.9 % Arm: serious adverse events
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. Voluven® Arm vs NaCl 0.9 % Arm: serious adverse events. Trial comparisons, record NCT00464204-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00464204-sae
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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 | 0.53 | 0.433 | 0.625 | wilson | |
| Risk in group 2 | 0.458 | 0.362 | 0.558 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0717 | -0.0673 | 0.207 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.16 | 0.869 | 1.54 | log | |
| Odds ratio, group 1 over group 2 | 1.33 | 0.76 | 2.34 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Voluven® Arm than on NaCl 0.9 % Arm | 14 | 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 | Voluven® Arm | 6 % Hydroxyethylstarch 130/0.4; Voluven® rates were not to exceed 50 mL/kg/day on the first days and 25 mL/kg/day from the second to the fourth day | 53 | 100 | EG000 |
| Group 2 | NaCl 0.9 % Arm | NaCl 0.9 %; NaCl 0.9 % rates were not to exceed 50 mL/kg/day on the first day and 25 mL/kg/day from the second to the fourth day | 44 | 96 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Source ClinicalTrials.gov
Trial
- Title
- Effects of Voluven on Hemodynamics and Tolerability of Enteral Nutrition in Patients With Severe Sepsis
- NCT number
- NCT00464204
- Phases
- PHASE3
- Conditions
- Sepsis
- Interventions
- 6 % Hydroxyethylstarch 130/0.4 = "Voluven®", 0.9 % NaCl
- Lead sponsor
- Fresenius Kabi
- Results first posted
- 2011-08-02
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00464204?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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