Comparison · NCT00836875-sae
Voriconazole: 2 to <12 Years vs Voriconazole: 12 to <18 Years: 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. Voriconazole: 2 to <12 Years vs Voriconazole: 12 to <18 Years: serious adverse events. Trial comparisons, record NCT00836875-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00836875-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 | 0.545 | 0.28 | 0.787 | wilson | |
| Risk in group 2 | 0.45 | 0.258 | 0.658 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0955 | -0.242 | 0.404 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.21 | 0.587 | 2.5 | log | |
| Odds ratio, group 1 over group 2 | 1.47 | 0.335 | 6.43 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Voriconazole: 2 to <12 Years than on Voriconazole: 12 to <18 Years | 10.5 | 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 | Voriconazole: 2 to <12 Years | Participants aged 2 to less than (\<)12 years (and young adolescents aged 12 to 14 years weighing \<50 kilograms \[kg\]) received a loading dose of voriconazole of 9 milligrams per kg (mg/kg), intravenously (IV), every 12 hours (q12h) for the first 24 hours, followed by maintenance dosing of 8 mg/kg IV q12h for a minimum of 7 days of IV therapy. Once significant clinical improvement was observed, participants could have been switched or oral (PO) therapy and received 9 mg/kg PO voriconazole q12h for a maximum dose of 350 mg. | 6 | 11 | EG000 |
| Group 2 | Voriconazole: 12 to <18 Years | Participants aged 12 to \<18 years (excluding those aged 12-14 years weighing \<50 kg) received a loading dose of 6 mg/kg IV q12h for the first 24 hours followed by maintenance dosing of 4 mg/kg IV q12h for a minimum of 7 days of IV therapy. Once significant clinical improvement was observed, participants could have been switched or oral therapy and received 200-300 mg PO q12h. | 9 | 20 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Source ClinicalTrials.gov
Trial
- Title
- A Study To Evaluate The Safety Of Voriconazole As Treatment Of Invasive Aspergillosis (Fungal Infection) And Other Rare Molds In Children
- NCT number
- NCT00836875
- Phases
- PHASE3
- Conditions
- Invasive Aspergillosis
- Interventions
- Voriconazole
- Lead sponsor
- Pfizer
- Results first posted
- 2014-06-23
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00836875?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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