Comparison · NCT01205126-sae
Hydromorphone Hydrochloride (HCl) vs Oxycodone HCl Controlled Release (CR): serious adverse events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
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ConductScience Library. Hydromorphone Hydrochloride (HCl) vs Oxycodone HCl Controlled Release (CR): serious adverse events. Trial comparisons, record NCT01205126-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01205126-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 | 0.0859 | 0.0487 | 0.147 | wilson | |
| Risk in group 2 | 0.143 | 0.0923 | 0.215 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0569 | -0.138 | 0.0226 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.602 | 0.296 | 1.22 | log | |
| Odds ratio, group 1 over group 2 | 0.564 | 0.255 | 1.25 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Hydromorphone Hydrochloride (HCl) than on Oxycodone HCl Controlled Release (CR) | 17.6 | 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 | Hydromorphone Hydrochloride (HCl) | Osmotic Release Oral System (OROS) hydromorphone HCl was administered in dose of 8, 16, 24, and 32 milligram (mg), once daily for 2 to 8 days of titration phase and 28 days of maintenance phase. Starting dose was based on participant's previous daily opioid dose. | 11 | 128 | EG000 |
| Group 2 | Oxycodone HCl Controlled Release (CR) | Oxycodone HCl was administered in dose of 10, 20, 30, and 40 mg, twice daily for 2 to 8 days of titration phase and 28 days of maintenance phase. Starting dose was based on participant's previous daily opioid dose. | 18 | 126 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Screening phase up to 30 days after last dose of study medication
Source ClinicalTrials.gov
Trial
- Title
- An Efficacy and Safety Study of Oral Osmotic Therapeutic System (OROS) Hydromorphone Hydrochloride (HCl) in Participants With Cancer Related Pain
- NCT number
- NCT01205126
- Phases
- PHASE3
- Conditions
- Pain
- Interventions
- Hydromorphone HCl, Oxycodone HCl CR, Placebo
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
- Results first posted
- 2013-11-25
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01205126?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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