Comparison · NCT01629563-sae
Ulipristal Acetate (PGL4001) 5mg vs Ulipristal Acetate (PGL4001) 10mg: serious 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. Ulipristal Acetate (PGL4001) 5mg vs Ulipristal Acetate (PGL4001) 10mg: serious adverse events. Trial comparisons, record NCT01629563-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01629563-sae
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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 | 0.0696 | 0.0433 | 0.11 | wilson | |
| Risk in group 2 | 0.0543 | 0.0313 | 0.0925 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0153 | -0.0311 | 0.0618 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.28 | 0.62 | 2.65 | log | |
| Odds ratio, group 1 over group 2 | 1.3 | 0.602 | 2.82 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Ulipristal Acetate (PGL4001) 5mg than on Ulipristal Acetate (PGL4001) 10mg | 65.5 | from the risk difference interval | the interval includes no difference |
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 | Ulipristal Acetate (PGL4001) 5mg | PGL4001 5 mg: PGL4001 5 mg daily administration | 16 | 230 | EG000 |
| Group 2 | Ulipristal Acetate (PGL4001) 10mg | PGL4001 10 mg: PGL4001 10mg daily administration | 12 | 221 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Serious Adverse events were reported where the start date was on or after the first dose of study medication, up to the end of study follow-up (21 months on average).Other Adverse Events are summarised as on-treatment TEAEs.
Source ClinicalTrials.gov
Trial
- Title
- PGL4001 Efficacy Assessment in Reduction of Symptoms Due to Uterine Leiomyomata
- NCT number
- NCT01629563
- Phases
- PHASE3
- Conditions
- Uterine Fibroids
- Interventions
- PGL4001 5 mg, PGL4001 10 mg
- Lead sponsor
- PregLem SA
- Results first posted
- 2019-09-04
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01629563?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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