Comparison · NCT00559364-sae
Viokase® vs Placebo: 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. Viokase® vs Placebo: serious adverse events. Trial comparisons, record NCT00559364-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00559364-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 | 0.0667 | 0.0185 | 0.213 | wilson | |
| Risk in group 2 | 0 | 0 | 0.161 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0667 | -0.102 | 0.213 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | log | a group has no participants with the outcome | |||
| Odds ratio, group 1 over group 2 | log | a cell of the two-by-two table is zero | |||
| Number needed to harm, for one more participant with a serious adverse event on Viokase® than on Placebo | 15 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Viokase® | Patients received Viokase® 16, 22 tablets orally daily (that is, 6 tablets per meal and 2 tablets with 2 of 3 snacks) for 6 to 7 days in treatment phase. Patients on proton pump inhibitor (PPI) therapy during Screening continued their usual (those not using PPI therapy at screening received omeprazole 20 milligram orally once daily) throughout the study. | 2 | 30 | EG000 |
| Group 2 | Placebo | Patients received matching placebo, 22 tablets orally daily (that is, 6 tablets per meal and 2 tablets with 2 of 3 snacks) for 6 to 7 days in treatment phase. Patients on proton pump inhibitor (PPI) therapy during Screening continued their usual (those not using PPI therapy at screening received omeprazole 20 milligram orally once daily) throughout the study. | 0 | 20 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Day 1 of treatment phase up to 30 days after last dose administration
Source ClinicalTrials.gov
Trial
- Title
- Safety and Efficacy Study of Viokase® 16 for the Correction of Steatorrhea
- NCT number
- NCT00559364
- Phases
- PHASE3
- Conditions
- Exocrine Pancreatic Insufficiency, Chronic Pancreatitis, Pancreatectomy
- Interventions
- Viokase® 16, Placebo, Proton pump inhibitor (PPI), Omeprazole
- Lead sponsor
- Forest Laboratories
- Results first posted
- 2014-03-12
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00559364?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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Read this comparison from software.
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