Comparison · NCT04122443-81a30580
Ibuprofen and Then Acetaminophen (Stage 2) vs Ibuprofen and Then Oxycodone/Acetaminophen (Stage 2): Medication-related 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. Ibuprofen and Then Acetaminophen (Stage 2) vs Ibuprofen and Then Oxycodone/Acetaminophen (Stage 2): Medication-related Adverse Events. Trial comparisons, record NCT04122443-81a30580. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04122443-81a30580
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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 | 0.0946 | 0.0466 | 0.183 | wilson | |
| Risk in group 2 | 0.342 | 0.245 | 0.454 | wilson | |
| Risk difference, group 1 minus group 2 | -0.248 | -0.369 | -0.117 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.277 | 0.128 | 0.598 | log | |
| Odds ratio, group 1 over group 2 | 0.201 | 0.0808 | 0.5 | log | |
| Number needed to treat, for one fewer participant with the outcome on Ibuprofen and Then Acetaminophen (Stage 2) than on Ibuprofen and Then Oxycodone/Acetaminophen (Stage 2) | 4.04 | 2.71 | 8.57 | 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 | Ibuprofen and Then Acetaminophen (Stage 2) | Ibuprofen - 600mg PO (Stage 1, Open label)~Acetaminophen alone (Stage 2, Double blinded)~Acetaminophen: Acetaminophen 650mg PO | 7 | 74 | OG000 |
| Group 2 | Ibuprofen and Then Oxycodone/Acetaminophen (Stage 2) | Ibuprofen - 600mg PO (Stage 1, Open label)~Oxycodone + Acetaminophen (Stage 2, Double blinded)~Acetaminophen: Acetaminophen 650mg PO~Oxycodone: Oxycodone 10mg PO | 26 | 76 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Medication-related Adverse Events
- Description
- Stage 1 (Open label): No Outcome Measures assessed~Stage 2 (Double blinded): The number of participants demonstrating medication-related adverse events was tabulated by treatment arm/group.
- Time frame
- 2 hours following treatment
- Population
- Responses for 3 participants in the 'Acetaminophen' arm and 1 participant in the 'Oxycodone + Acetaminophen' arm were unavailable.
Source ClinicalTrials.gov
Trial
- Title
- Acetaminophen (APAP) +/- Oxycodone
- NCT number
- NCT04122443
- Phases
- PHASE4
- Conditions
- Musculoskeletal Pain
- Interventions
- Acetaminophen, Oxycodone
- Lead sponsor
- Montefiore Medical Center
- Results first posted
- 2024-02-28
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT04122443?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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