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Comparison · NCT01191944-sae

Pramipexole ER vs Pramipexole IR: 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. Pramipexole ER vs Pramipexole IR: serious adverse events. Trial comparisons, record NCT01191944-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01191944-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 10.02560.01180.0548wilson
Risk in group 20.05440.03210.0908wilson
Risk difference, group 1 minus group 2-0.0288-0.06770.00798newcombe hybrid score
Risk ratio, group 1 over group 20.4710.1821.22log
Odds ratio, group 1 over group 20.4570.1711.22log
Number needed to treat, for one fewer participant with a serious adverse event on Pramipexole ER than on Pramipexole IR34.8from 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 1Pramipexole ERPramipexole Extended Release (ER). Tablets of 0.375 mg and 1.5 mg administered once daily (qd) to achieve daily doses of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg or 4.5 mg6234EG000
Group 2Pramipexole IRPramipexole Immediate Release (IR). Tablets of 0.125 mg, 0.25 mg and 1.0 mg administered 3 times daily to achieve a total daily dose of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg13239EG001

Harm

What it counts
Total, serious adverse events
Time frame
Up to 18 weeks

Source ClinicalTrials.gov

Trial

Title
Pramipexole Extended Release Versus Pramipexole Immediate Release for 18 Weeks in Chinese Parkinson's Disease (PD) Patients
NCT number
NCT01191944
Phases
PHASE3
Conditions
Parkinson Disease
Interventions
pramipexole immediate release tablet, pramipexole extended release tablet
Lead sponsor
Boehringer Ingelheim
Results first posted
2013-01-24

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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