Comparison · NCT01092832-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
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ConductScience Library. Voriconazole: 2 to <12 Years vs Voriconazole: 12 to <18 Years: serious adverse events. Trial comparisons, record NCT01092832-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01092832-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 | 0.143 | 0.0401 | 0.399 | wilson | |
| Risk in group 2 | 0.125 | 0.0224 | 0.471 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0179 | -0.343 | 0.294 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.14 | 0.122 | 10.7 | log | |
| Odds ratio, group 1 over group 2 | 1.17 | 0.0888 | 15.3 | 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 | 56 | 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 \<12 years (and young adolescents aged 12 to 14 years weighing \<50 kg) with ICC received a loading dose of voriconazole 9 mg/kg), IV, q12h for the first 24 hours, followed by maintenance dosing of voriconazole 8 mg/kg, IV, q12h for a minimum of 5 days of IV therapy. Participants with EC received voriconazole 4 mg/kg, IV, q12h for a minimum of 5 days of IV therapy. In both ICC and EC, once signs and symptoms of Candida infection had resolved and the participant was clinically stable, participants were switched to PO therapy and received voriconazole 9 mg/kg, PO, q12h (maximum dose of 350 mg). Voriconazole was administered for at least 7 days (participants with EC) or 14 days (participants with ICC) after last positive blood culture up to a maximum of 42 days of treatment. | 2 | 14 | EG000 |
| Group 2 | Voriconazole: 12 to <18 Years | Participants aged 12 to \<18 years (excluding those aged 12-14 years weighing \<50 kg) with ICC received a loading dose of voriconazole 6 mg/kg, IV, q12h for the first 24 hours, followed by maintenance dosing of voriconazole 4 mg/kg, IV, q12h for a minimum of 7 days of IV therapy. Participants with EC received voriconazole 3 mg/kg, IV, q12h for a minimum of 5 days of IV therapy. In both ICC and EC, once signs and symptoms of Candida infection had resolved and the participant was clinically stable, participants were switched to PO therapy and received voriconazole 200 mg, PO, q12h. Voriconazole was administered for at least 7 days (participants with EC) or 14 days (participants with ICC) after last positive blood culture up to a maximum of 42 days of treatment. | 1 | 8 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Day 1 up to Day 49 (7 days after the last dose of study drug)
Source ClinicalTrials.gov
Trial
- Title
- A Study Of The Safety, Tolerability And Effective Of Voriconazole For The Treatment Of Serious Candida Infection And Candida Infection Of The Throat In Pediatric Patients
- NCT number
- NCT01092832
- Phases
- PHASE3
- Conditions
- Candidiasis
- Interventions
- voriconazole
- Lead sponsor
- Pfizer
- Results first posted
- 2015-08-17
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01092832?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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GET https://conductscience.org/api/comparisons/v1/NCT01092832-sae