Comparison · NCT06173869-sae
FE 999049 vs GONAL-F: 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. FE 999049 vs GONAL-F: serious adverse events. Trial comparisons, record NCT06173869-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT06173869-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 | 0.027 | 0.0106 | 0.0674 | wilson | |
| Risk in group 2 | 0.0719 | 0.0406 | 0.124 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0449 | -0.0997 | 0.00622 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.376 | 0.122 | 1.15 | log | |
| Odds ratio, group 1 over group 2 | 0.359 | 0.112 | 1.15 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on FE 999049 than on GONAL-F | 22.3 | 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 | FE 999049 | The participants received either low or high starting dose as appropriate according to Investigators Judgement.~10 or 15 µg~FE 999049: FE 999049 was administered as single daily subcutaneous injections at a starting dose of either 10 or 15 µg daily that was fixed for the first five stimulation days. Based on ovarian response, the dose was increased or decreased by 5 µg, with dose adjustments implemented not more frequently than once every 2 days per investigator's judgement. The minimum daily dose was 5 µg, and the maximum daily dose was 20 µg. Participants were treated for a maximum of 20 days. | 4 | 148 | EG000 |
| Group 2 | GONAL-F | The participants received either low or high starting dose as appropriate according to Investigators Judgement.~150 or 225 IU.~GONAL-F: GONAL-F was administered as single daily subcutaneous injections at a starting dose of either 150 or 225 IU daily that was fixed for the first five stimulation days. Based on ovarian response, the dose was increased or decreased by 75 IU, with dose adjustments implemented not more frequently than once every 2 days per investigator's judgement. The minimum daily dose was 75 IU, and the maximum daily dose was 300 IU. Participants were treated for a maximum of 20 days.~Coasting was not allowed. | 11 | 153 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- 12 months
Source ClinicalTrials.gov
Trial
- Title
A Randomised Trial Comparing the Ovarian Response of a Starting Dose of Either 10 μg or 15 μg Follitropin Delta (FE 999049) to a Starting Dose of Either 150 IU or 225 IU Follitropin Alfa (GONAL-F) in Conventional Regimens in China
- NCT number
- NCT06173869
- Phases
- PHASE3
- Conditions
- Infertility, Female
- Interventions
- FE 999049, GONAL-F
- Lead sponsor
- Ferring Pharmaceuticals
- Results first posted
- 2026-02-12
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT06173869?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
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