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Comparison · NCT01885182-sae

Oxycodone/Naloxone vs Oxycodone: 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. Oxycodone/Naloxone vs Oxycodone: serious adverse events. Trial comparisons, record NCT01885182-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01885182-sae

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Measures6

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

MeasureValue95% interval, lower95% interval, upperMethodNote
Risk in group 10.1230.07460.196wilson
Risk in group 20.1080.06290.18wilson
Risk difference, group 1 minus group 20.0147-0.07150.1newcombe hybrid score
Risk ratio, group 1 over group 21.140.552.35log
Odds ratio, group 1 over group 21.160.5092.62log
Number needed to harm, for one more participant with a serious adverse event on Oxycodone/Naloxone than on Oxycodone68from the risk difference intervalthe interval includes no difference

Groups2

Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.

GroupTitleDescriptionWith the outcomeAnalysedClinicalTrials.gov code
Group 1Oxycodone/Naloxone5/2.5mg, 10/5mg, 20/10mg or 40/20mg~Oxycodone/Naloxone14114EG000
Group 2Oxycodone5mg, 10mg, 20mg or 40mg~Oxycodone12111EG001

Harm

What it counts
Total, serious adverse events
Time frame
The adverse event data were collected from 2013 Jun to 2014 Aug, which is about 14 months. The time frame of AE collection for each subject is about 6 weeks.

Source ClinicalTrials.gov

Trial

Title
Determine the Safety and Efficacy of Oxy/Nal Tablets Compared to Oxy PR in Subjects With Cancer Pain
NCT number
NCT01885182
Phases
PHASE3
Conditions
Cancer, Pain
Interventions
Oxycodone/Naloxone, Oxycodone
Lead sponsor
Mundipharma (China) Pharmaceutical Co. Ltd
Results first posted
2019-09-16

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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