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Comparison · NCT00141102-82861d03

Celecoxib vs Oral Diclofenac Plus Omeprazole: Number of Subjects Withdrawn Due to GI Adverse Events (AEs)

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. Celecoxib vs Oral Diclofenac Plus Omeprazole: Number of Subjects Withdrawn Due to GI Adverse Events (AEs). Trial comparisons, record NCT00141102-82861d03. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00141102-82861d03

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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 10.05090.04260.0608wilson
Risk in group 20.07440.06420.0859wilson
Risk difference, group 1 minus group 2-0.0234-0.0377-0.00924newcombe hybrid score
Risk ratio, group 1 over group 20.6850.5440.863log
Odds ratio, group 1 over group 20.6680.5230.854log
Number needed to treat, for one fewer participant with the outcome on Celecoxib than on Oral Diclofenac Plus Omeprazole42.726.5108from the risk difference interval

Groups2

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

GroupTitleDescriptionWith the outcomeAnalysedClinicalTrials.gov code
Group 1Celecoxib200 mg BID plus omeprazole placebo and diclofenac SR placebo1142,238OG000
Group 2Oral Diclofenac Plus OmeprazoleOral diclofenac SR (75 mg BID) plus omeprazole (20 mg QD) and celecoxib placebo.1672,246OG001

Outcome

Type
SECONDARY
Title
Number of Subjects Withdrawn Due to GI Adverse Events (AEs)
Description
GI AEs were defined using MedDRA SOC Gastrointestinal Disorders but excluding the following HLGTs: Benign Neoplasms Gastrointestinal; Dental and Gingival Conditions; Oral Soft Tissue Conditions; Salivary Gland Conditions; and Tongue Conditions.
Time frame
6 month treatment duration
Population
ITT

Source ClinicalTrials.gov

Trial

Title
Study Of Celecoxib Or Diclofenac And Omeprazole For Gastrointestinal (GI) Safety In High GI Risk Patients With Arthritis
NCT number
NCT00141102
Phases
PHASE4
Conditions
Osteoarthritis, Arthritis, Rheumatoid
Interventions
Celecoxib, Diclofenac + Omeprazole
Lead sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Results first posted
2010-06-11

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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