Comparison · NCT00423267-b44a6fa3
Posaconazole vs Fluconazole: Number of Participants With Treatment-emergent Adverse Events (TEAEs)That Occurred With POS or FLU in Period A
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. Posaconazole vs Fluconazole: Number of Participants With Treatment-emergent Adverse Events (TEAEs)That Occurred With POS or FLU in Period A. Trial comparisons, record NCT00423267-b44a6fa3. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00423267-b44a6fa3
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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 | 0.889 | 0.565 | 0.98 | wilson | |
| Risk in group 2 | 0.714 | 0.359 | 0.918 | wilson | |
| Risk difference, group 1 minus group 2 | 0.175 | -0.208 | 0.541 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.24 | 0.738 | 2.1 | log | |
| Odds ratio, group 1 over group 2 | 3.2 | 0.227 | 45.2 | log | |
| Number needed to treat, for one more participant with the outcome on Posaconazole than on Fluconazole | 5.73 | 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 | Posaconazole | Eligible subjects will be stratified at Baseline by disease site (skeletal, lung, or soft tissue) and by immune status (immunocompromised or non-immunocompromised) and will then be randomly assigned to receive Posaconazole 400 mg orally (PO) (oral suspension 40 mg/mL) administered twice daily with meals or oral nutritional supplements for 12 months. | 8 | 9 | OG000 |
| Group 2 | Fluconazole | Eligible subjects will be stratified at Baseline by disease site (skeletal, lung, or soft tissue) and by immune status (immunocompromised or non-immunocompromised) and will then be randomly assigned to receive Fluconazole 400 mg PO (given as two 200-mg oral encapsulated tablets) administered once daily for 12 months. Fluconazole treatment or placebo only occurred during Period A. Participants in this arm were given posaconazole in Period B. | 5 | 7 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Participants With Treatment-emergent Adverse Events (TEAEs)That Occurred With POS or FLU in Period A
- Description
- Treatment-emergent adverse events are defined as new events that occur following subject entry into the study or events that worsen following study entry state.
- Time frame
- 12 months
- Population
Source ClinicalTrials.gov
Trial
- Title
- POS vs FLU for First Line Treatment of Coccidioidomycosis (Study P04558Am1)(COMPLETED)
- NCT number
- NCT00423267
- Phases
- PHASE3
- Conditions
- Coccidioidomycosis
- Interventions
- Posaconazole, Fluconazole
- Lead sponsor
- Merck Sharp & Dohme LLC
- Results first posted
- 2010-06-30
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00423267?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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