Comparison · NCT00150345-sae
Immediate Voriconazole vs Deferred Voriconazole Treatment: serious adverse events
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. Immediate Voriconazole vs Deferred Voriconazole Treatment: serious adverse events. Trial comparisons, record NCT00150345-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00150345-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 | 0.0988 | 0.0509 | 0.183 | wilson | |
| Risk in group 2 | 0.121 | 0.0627 | 0.221 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0224 | -0.133 | 0.0801 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.815 | 0.323 | 2.05 | log | |
| Odds ratio, group 1 over group 2 | 0.795 | 0.281 | 2.25 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Immediate Voriconazole than on Deferred Voriconazole Treatment | 44.5 | 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 | Immediate Voriconazole | Voriconazole intravenous (IV) loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). Continued treatment with oral (PO) voriconazole 200 mg twice a day (BID) through Day 28. Treatment ended if the participant was afebrile (\< 38.0 degrees Celsius \[C\]) for 7 days with neutrophil counts \< 500 per microliter (500/uL) or if participant was afebrile (\< 38.0 degrees C) for 2 days with neutrophil counts \> 500/uL. | 8 | 81 | EG000 |
| Group 2 | Deferred Voriconazole Treatment | Placebo IV loading dose of 6 mg/kg every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). On Day 5, voriconazole IV loading dose of 6 mg/kg every 12 hours for at least 4 days (up to Day 9). Continued treatment with PO voriconazole 200 mg BID through Day 28. Treatment ended if the participant was afebrile (\< 38.0 degrees C) for 7 days with neutrophil counts \< 500/uL or if participant was afebrile (\< 38.0 degrees C) for 2 days with neutrophil counts \> 500/uL. | 8 | 66 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Baseline up to 7 days after last dose of study drug
Source ClinicalTrials.gov
Trial
- Title
- Immediate vs. Deferred Empirical Antifungal Treatment With Voriconazole In Neutropenic Patients
- NCT number
- NCT00150345
- Phases
- PHASE3
- Conditions
- Possible Fungal Infection
- Interventions
- voriconazole (Vfend), voriconazole (Vfend)
- Lead sponsor
- Pfizer
- Results first posted
- 2010-08-18
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00150345?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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