Comparison · NCT00413218-sae
Isavuconazole (ISA) vs Caspofungin (CAS)/Voriconazole: 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. Isavuconazole (ISA) vs Caspofungin (CAS)/Voriconazole: serious adverse events. Trial comparisons, record NCT00413218-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00413218-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 | 0.509 | 0.443 | 0.574 | wilson | |
| Risk in group 2 | 0.482 | 0.417 | 0.548 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0273 | -0.0657 | 0.12 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.06 | 0.875 | 1.28 | log | |
| Odds ratio, group 1 over group 2 | 1.12 | 0.767 | 1.62 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Isavuconazole (ISA) than on Caspofungin (CAS)/Voriconazole | 36.7 | 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 | Isavuconazole (ISA) | Participants received 3 intravenous (IV) loading doses of 200 mg of isavuconazole on days 1 and 2, followed by an IV maintenance dose of 200 mg once daily from day 3 to day 56. On day 11 at the discretion of the investigator, non-neutropenic patients could switch from IV to oral therapy. Oral therapy consisted of 200 mg isavuconazole once daily. | 112 | 220 | EG000 |
| Group 2 | Caspofungin (CAS)/Voriconazole | Participants received 1 intravenous (IV) loading dose of 70 mg CAS on day 1, followed by an IV maintenance dose of 50 mg CAS from day 2 to day 56. Participants with body weight \> 80 kg received 70 mg CAS daily. On day 11 at the discretion of the investigator, non-neutropenic patients could switch from IV CAS to oral voriconazole comprising of a loading dose of 400 mg twice daily (BID) on the first day of oral therapy followed by standard dosing of 200 mg BID thereafter. | 106 | 220 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Day 1 to FU2 (6 weeks after EOT (Day 56))
Source ClinicalTrials.gov
Trial
- Title
- Isavuconazole (BAL8557) in the Treatment of Candidemia and Other Invasive Candida Infections
- NCT number
- NCT00413218
- Phases
- PHASE3
- Conditions
- Candidiasis, Invasive, Candidemia, Mycoses
- Interventions
- Isavuconazole, Caspofungin, Voriconazole
- Lead sponsor
- Astellas Pharma Inc
- Results first posted
- 2017-08-01
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00413218?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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