Comparison · NCT01165320-sae
Participants With Invasive Candidiasis vs Participants With Aspergillosis: 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. Participants With Invasive Candidiasis vs Participants With Aspergillosis: serious adverse events. Trial comparisons, record NCT01165320-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01165320-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 | 0.0833 | 0.0149 | 0.354 | wilson | |
| Risk in group 2 | 0.25 | 0.0715 | 0.591 | wilson | |
| Risk difference, group 1 minus group 2 | -0.167 | -0.514 | 0.157 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.333 | 0.0359 | 3.09 | log | |
| Odds ratio, group 1 over group 2 | 0.273 | 0.0203 | 3.67 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Participants With Invasive Candidiasis than on Participants With Aspergillosis | 6 | 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 | Participants With Invasive Candidiasis | MK-0991 therapy as a single loading dose of 70 mg/m\^2 intravenously on Day 1 (maximum not to exceed 70 mg), followed by 50 mg/m\^2 as a single once-daily dose on all subsequent days (maximum of 70 mg daily). The minimum and maximum treatment duration was 14 and 56 days, respectively. | 1 | 12 | EG000 |
| Group 2 | Participants With Aspergillosis | MK-0991 therapy as a single loading dose of 70 mg/m\^2 intravenously on Day 1 (maximum not to exceed 70 mg), followed by 50 mg/m\^2 as a single once-daily dose on all subsequent days (maximum of 70 mg daily). The minimum and maximum treatment duration was 14 and 84 days, respectively. | 2 | 8 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Invasive candidiasis: up to 56 days; aspergillosis: up to 84 days
Source ClinicalTrials.gov
Trial
- Title
- A Study of Caspofungin (MK-0991) in Japanese Children and Adolescents With Documented Candida or Aspergillus Infections (MK-0991-074)
- NCT number
- NCT01165320
- Phases
- PHASE2
- Conditions
- Candidiasis, Esophageal, Candidiasis, Invasive, Aspergillosis
- Interventions
- Caspofungin
- Lead sponsor
- Merck Sharp & Dohme LLC
- Results first posted
- 2014-04-23
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01165320?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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