Comparison · NCT00973973-sae
Elagolix vs Placebo: 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. Elagolix vs Placebo: serious adverse events. Trial comparisons, record NCT00973973-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00973973-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 | 0.00763 | 0.00135 | 0.042 | wilson | |
| Risk in group 2 | 0.0435 | 0.0149 | 0.12 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0358 | -0.113 | 0.00883 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.176 | 0.0186 | 1.66 | log | |
| Odds ratio, group 1 over group 2 | 0.169 | 0.0173 | 1.66 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Elagolix than on Placebo | 27.9 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Elagolix | Participants initially randomized to elagolix received 150 mg elagolix orally once a day for 8 weeks during the double-blind treatment period and continued to receive 150 mg elagolix for 16 additional weeks during the open-label treatment period.~Participants originally randomized to placebo were switched to receive 150 mg elagolix for 16 weeks during the open-label treatment period. | 1 | 131 | EG001 |
| Group 2 | Placebo | Participants received placebo orally once a day for 8 weeks during the double-blind treatment period. | 3 | 69 | EG000 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
From the first dose of any study drug through week 24. The Placebo treatment group includes data for the 8-week double-blind treatment phase. The Elagolix treatment group included data for the total 24-week treatment period for participants initially randomized to elagolix, and 16-week open-label treatment period for participants initially randomized to placebo.
Source ClinicalTrials.gov
Trial
- Title
- Efficacy and Safety Study of Elagolix in Women With Endometriosis
- NCT number
- NCT00973973
- Phases
- PHASE2
- Conditions
- Endometriosis, Pain
- Interventions
- Placebo, Elagolix
- Lead sponsor
- AbbVie
- Results first posted
- 2018-09-26
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00973973?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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