Comparison · NCT00626431-sae
Leuprolide Acetate - Formulation A vs Leuprolide Acetate - Formulation B: 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. Leuprolide Acetate - Formulation A vs Leuprolide Acetate - Formulation B: serious adverse events. Trial comparisons, record NCT00626431-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00626431-sae
On this page
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 | 0.205 | 0.149 | 0.277 | wilson | |
| Risk in group 2 | 0.258 | 0.196 | 0.331 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0526 | -0.145 | 0.0418 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.796 | 0.528 | 1.2 | log | |
| Odds ratio, group 1 over group 2 | 0.743 | 0.437 | 1.26 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Leuprolide Acetate - Formulation A than on Leuprolide Acetate - Formulation B | 19 | 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 | Leuprolide Acetate - Formulation A | Leuprolide acetate 45 mg, 6-month depot administered as 2 intramuscular (IM) injections of Formulation A, 24 weeks apart. Injections were administered on Day 1 and Day 169. The first 150 subjects were to receive Formulation A and then the next 150 subjects were to receive Formulation B in a sequential manner. | 31 | 151 | EG000 |
| Group 2 | Leuprolide Acetate - Formulation B | Leuprolide acetate 45 mg, 6-month depot administered as 2 intramuscular injections of Formulation B, 24 weeks apart. Injections were administered on Day 1 and Day 169. The first 150 subjects were to receive Formulation A and then the next 150 subjects were to receive Formulation B in a sequential manner. | 41 | 159 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Both serious adverse events and adverse events were reported from the receipt of the first dose of study drug through the 30-day follow-up period.
Source ClinicalTrials.gov
Trial
- Title
- A Study of Leuprolide to Treat Prostate Cancer
- NCT number
- NCT00626431
- Phases
- PHASE3
- Conditions
- Prostate Cancer
- Interventions
- Leuprolide acetate - Formulation A, Leuprolide acetate - Formulation B
- Lead sponsor
- Abbott
- Results first posted
- 2010-11-01
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00626431?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.
For software
Read this comparison from software.
The record is JSON. No key.
GET https://conductscience.org/api/comparisons/v1/NCT00626431-sae