Comparison · NCT01497197-sae
Gonal-f®+Luveris vs Gonal-f® Followed by Luveris: 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. Gonal-f®+Luveris vs Gonal-f® Followed by Luveris: serious adverse events. Trial comparisons, record NCT01497197-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01497197-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 | 0.0449 | 0.0176 | 0.11 | wilson | |
| Risk in group 2 | 0.0588 | 0.0254 | 0.13 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0139 | -0.0905 | 0.0592 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.764 | 0.212 | 2.75 | log | |
| Odds ratio, group 1 over group 2 | 0.753 | 0.195 | 2.9 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Gonal-f®+Luveris than on Gonal-f® Followed by Luveris | 72 | 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 | Gonal-f®+Luveris | GONAL f® 300 international units \[IU\] per day as subcutaneous injection using liquid pen from stimulation Day 1-5 followed by Luveris® 150 IU per day lyophilized powder for subcutaneous injection from stimulation Day 1 until required recombinant human chorionic gonadotropin (r-hCG) level was met. The dose was adjusted from stimulation Day 6 (increased or decreased) based upon the subject's ovarian response and according to the center's standard practice. | 4 | 89 | EG000 |
| Group 2 | Gonal-f® Followed by Luveris | GONAL-f® 300 IU per day as subcutaneous injection using liquid pen from stimulation Day 1-5 followed by Luveris® 150 IU per day lyophilized powder for subcutaneous injection from stimulation Day 6 until required r-hCG level was met. The dose was adjusted from stimulation Day 6 (increased or decreased) based upon the subject's ovarian response and according to the center's standard practice. | 5 | 85 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Baseline up to 15-20 days post r-hCG administration
Source ClinicalTrials.gov
Trial
- Title
- A Trial to Compare the Efficacy and Safety of Ovarian Stimulation With GONAL-f® and Luveris® Starting on Day 1 Versus Day 6 in Women Undergoing Assisted Reproductive Technique
- NCT number
- NCT01497197
- Phases
- PHASE3
- Conditions
- Infertility, Fertility, Follicle Stimulating Hormone Deficiency
- Interventions
- GONAL-f®, Luveris®, Recombinant human chorionic gonadotropin (r-hCG)
- Lead sponsor
- Merck KGaA, Darmstadt, Germany
- Results first posted
- 2015-11-09
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01497197?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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