Comparison · NCT01956110-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 NCT01956110-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01956110-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 | 0.0241 | 0.0149 | 0.0387 | wilson | |
| Risk in group 2 | 0.0151 | 0.00824 | 0.0276 | wilson | |
| Risk difference, group 1 minus group 2 | 0.00893 | -0.00658 | 0.0251 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.59 | 0.727 | 3.48 | log | |
| Odds ratio, group 1 over group 2 | 1.6 | 0.723 | 3.56 | log | |
| Number needed to harm, for one more participant with a serious adverse event on FE 999049 than on GONAL-F | 112 | 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 | FE 999049 was administered as single daily subcutaneous injections in the abdomen. Subjects randomised to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomisation. The daily FE 999049 dose was fixed throughout the stimulation period and maximum allowed daily dose was 12 μg. Dosing continued until the criterion for triggering of final follicular maturation was met. Subjects could be treated for a maximum of 20 days. | 16 | 665 | EG000 |
| Group 2 | GONAL-F | GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose of GONAL-F was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Subjects could be treated for a maximum of 20 days. | 10 | 661 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Adverse events (AEs) were recorded from signed informed consent to the end-of-trial (up to approximately 5.5 months).
Source ClinicalTrials.gov
Trial
- Title
- Evidence-based Stimulation Trial With Human rFSH in Europe and Rest of World 1
- NCT number
- NCT01956110
- Phases
- PHASE3
- Conditions
- Infertility
- Interventions
- Follitropin Delta (FE 999049), Follitropin Alfa (GONAL-F)
- Lead sponsor
- Ferring Pharmaceuticals
- Results first posted
- 2018-09-25
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01956110?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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