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Comparison · NCT01912716-3dd52c8f

Standard Dose 100 mg vs High Dose 200mg: Number of Participants With Moderate or Severe Post-ERCP Pancreatitis

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. Standard Dose 100 mg vs High Dose 200mg: Number of Participants With Moderate or Severe Post-ERCP Pancreatitis. Trial comparisons, record NCT01912716-3dd52c8f. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01912716-3dd52c8f

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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 10.05440.03790.0775wilson
Risk in group 20.05360.03740.0764wilson
Risk difference, group 1 minus group 20.000729-0.02740.029newcombe hybrid score
Risk ratio, group 1 over group 21.010.6091.69log
Odds ratio, group 1 over group 21.010.5921.74log
Number needed to treat, for one more participant with the outcome on Standard Dose 100 mg than on High Dose 200mg1,370from 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 1Standard Dose 100 mgpatients receiving 100mg indomethacin28515OG000
Group 2High Dose 200mgpatients receiving 200mg indomethacin28522OG001

Outcome

Type
SECONDARY
Title
Number of Participants With Moderate or Severe Post-ERCP Pancreatitis
Description
Assessment of whether patients developed either moderate or severe post-ERCP pancreatitis, defined according to established consensus criteria (Cotton et al., Gastrointestinal Endoscopy 1991;37:383-93). Severity of post-ERCP pancreatitis is partly defined according to length of stay. Moderate pancreatitis is defined as a 4-10 day hospitalization. Severe post-ERCP pancreatitis is defined as a hospitalization of greater than 10 days post-ERCP, or development of a complication (eg. pseudocyst or necrosis), or need for intervention (drainage or surgery).
Time frame
30 days
Population
development of moderate or severe post-ERCP pancreatitis

Source ClinicalTrials.gov

Trial

Title
Rectal Indomethacin in the Prevention of Post-ERCP Pancreatitis
NCT number
NCT01912716
Phases
PHASE2, PHASE3
Conditions
Post-ERCP Pancreatitis
Interventions
high dose indomethacin, standard dose indomethacin
Lead sponsor
Indiana University
Results first posted
2019-06-18

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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