Comparison · NCT01115569-sae
Conversion/Titration Phase vs Maintenance Treatment Phase: 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. Conversion/Titration Phase vs Maintenance Treatment Phase: serious adverse events. Trial comparisons, record NCT01115569-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01115569-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 | 0.0408 | 0.028 | 0.059 | wilson | |
| Risk in group 2 | 0.172 | 0.139 | 0.211 | wilson | |
| Risk difference, group 1 minus group 2 | -0.131 | -0.172 | -0.0937 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.237 | 0.154 | 0.364 | log | |
| Odds ratio, group 1 over group 2 | 0.204 | 0.128 | 0.326 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Conversion/Titration Phase than on Maintenance Treatment Phase | 7.61 | 5.8 | 10.7 | 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 | Conversion/Titration Phase | Conversion/Titration Phase: Hydrocodone Bitartrate Extended Release (HC-ER) capsules daily for up to 6 weeks | 26 | 638 | EG000 |
| Group 2 | Maintenance Treatment Phase | Maintenance Hydrocodone Bitartrate Extended Release (HC-ER) Treatment Phase: Open-label, all patients fulfilling the protocol Inclusion/Exclusion criteria will receive HC-CR in a flexible dosing regimen.~Hydrocodone Bitartrate: Open-Label, Capsule Strengths 10 mg, 20 mg, 30 mg, 40 mg, 50 mg; by mouth (PO) twice a day (BID) for up to 48 weeks | 73 | 424 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Adverse events (AEs) were recorded up to 54 weeks, beginning at the Conversion and Titration Phase through 2 weeks after the last treatment administration (Treatment Phase).
Source ClinicalTrials.gov
Trial
- Title
- Long-Term Study of Hydrocodone Bitartrate Controlled-release Capsules in Subjects With Chronic Pain
- NCT number
- NCT01115569
- Phases
- PHASE3
- Conditions
- Chronic Pain
- Interventions
- Hydrocodone Bitartrate
- Lead sponsor
- Zogenix, Inc.
- Results first posted
- 2014-04-25
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01115569?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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