Comparison · NCT00634049-sae
Renally Impaired (RI) vs Not Renally Impaired (NRI): 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. Renally Impaired (RI) vs Not Renally Impaired (NRI): serious adverse events. Trial comparisons, record NCT00634049-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00634049-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 | 0.729 | 0.604 | 0.826 | wilson | |
| Risk in group 2 | 0.529 | 0.425 | 0.63 | wilson | |
| Risk difference, group 1 minus group 2 | 0.2 | 0.0393 | 0.342 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.38 | 1.07 | 1.77 | log | |
| Odds ratio, group 1 over group 2 | 2.4 | 1.18 | 4.88 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Renally Impaired (RI) than on Not Renally Impaired (NRI) | 5 | 2.92 | 25.5 | from the risk difference interval |
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 | Renally Impaired (RI) | Renal impairment was defined as yes for participants who have a baseline as eGFR \< 60 mL/min/1.73 m\^2 by the Modification of Diet in Renal Disease (MDRD) formula. | 43 | 59 | EG000 |
| Group 2 | Not Renally Impaired (NRI) | Not Renally impaired participants were defined as no if they have a baseline eGFR-MDRD ≥ 60 mL/min/1.73 m\^2 by the Modification of Diet in Renal Disease (MDRD) formula. | 46 | 87 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
From the first administration of study drug until 28 days after the last dose of study drug. For the days when IV and oral doses were administered on the same day, the day was split into one-half day for each route's duration.
Source ClinicalTrials.gov
Trial
- Title
- Isavuconazole in the Treatment of Renally Impaired Aspergillosis and Rare Fungi
- NCT number
- NCT00634049
- Phases
- PHASE3
- Conditions
- Aspergillosis, Invasive Fungal Infections
- Interventions
- isavuconazole
- Lead sponsor
- Astellas Pharma Inc
- Results first posted
- 2016-01-11
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00634049?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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