Comparison · NCT01400139-sae
HYD Core Study vs HYD Extension Period: 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. HYD Core Study vs HYD Extension Period: serious adverse events. Trial comparisons, record NCT01400139-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01400139-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 | 0.0868 | 0.0703 | 0.107 | wilson | |
| Risk in group 2 | 0.0566 | 0.0262 | 0.118 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0302 | -0.0334 | 0.0665 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.53 | 0.685 | 3.43 | log | |
| Odds ratio, group 1 over group 2 | 1.58 | 0.673 | 3.72 | log | |
| Number needed to harm, for one more participant with a serious adverse event on HYD Core Study than on HYD Extension Period | 33.2 | 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 | HYD Core Study | Hydrocodone bitartrate (HYD) once daily (q24h) tablets~Hydrocodone bitartrate q24h film-coated tablets: Hydrocodone bitartrate q24h film-coated tablets 20 - 120 mg once daily | 80 | 922 | EG000 |
| Group 2 | HYD Extension Period | Hydrocodone bitartrate (HYD) once daily (q24h) tablets~Hydrocodone bitartrate q24h film-coated tablets: Hydrocodone bitartrate q24h film-coated tablets 20 - 120 mg once daily | 6 | 106 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Adverse events (AEs) were reported from start of study participation through the period beyond study completion: up to 84 weeks.
Source ClinicalTrials.gov
Trial
- Title
- Long-term Safety of Once-daily Hydrocodone Bitartrate (HYD) Tablets For Moderate to Severe Chronic Nonmalignant and Nonneuropathic Pain. Includes a 24-week Extension Period.
- NCT number
- NCT01400139
- Phases
- PHASE3
- Conditions
- Chronic Nonmalignant and Nonneuropathic Pain
- Interventions
- Hydrocodone bitartrate q24h film-coated tablets
- Lead sponsor
- Purdue Pharma LP
- Results first posted
- 2014-12-04
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01400139?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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