Comparison · NCT01728246-sae
Tramadol/Paracetamol (APAP) vs Non-Tramadol/APAP: 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. Tramadol/Paracetamol (APAP) vs Non-Tramadol/APAP: serious adverse events. Trial comparisons, record NCT01728246-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01728246-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 | 0.00413 | 0.00073 | 0.023 | wilson | |
| Risk in group 2 | 0.00433 | 0.000765 | 0.0241 | wilson | |
| Risk difference, group 1 minus group 2 | -0.000197 | -0.0203 | 0.019 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.955 | 0.0601 | 15.2 | log | |
| Odds ratio, group 1 over group 2 | 0.954 | 0.0593 | 15.3 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Tramadol/Paracetamol (APAP) than on Non-Tramadol/APAP | 5,080 | 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 | Tramadol/Paracetamol (APAP) | Celecoxib 200 milligram (mg) administered orally once daily for 4 weeks and fixed dose combination of tramadol 37.5 mg/paracetamol 325 mg administered orally thrice daily for 4 weeks as add-on therapy. | 1 | 242 | EG000 |
| Group 2 | Non-Tramadol/APAP | Celecoxib 200 mg administered orally once daily for 4 weeks. | 1 | 231 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- From signing of informed consent until 30 days after the last dose of study medication
Source ClinicalTrials.gov
Trial
- Title
- An Efficacy, Safety and Effects on Quality of Life of Tramadol/Paracetamol as Add-on Therapy in Chronic Osteoarthritis
- NCT number
- NCT01728246
- Phases
- PHASE4
- Conditions
- Osteoarthritis
- Interventions
- Tramadol/Paracetamol (APAP), Non-Tramadol/APAP
- Lead sponsor
- Janssen Pharmaceutica
- Results first posted
- 2013-01-14
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01728246?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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