Comparison · NCT01297465-a7f20f9c
Gonal-f® Plus Pergoveris® vs Pergoveris®: Number of Participants With Treatment-emergent 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® Plus Pergoveris® vs Pergoveris®: Number of Participants With Treatment-emergent Adverse Events. Trial comparisons, record NCT01297465-a7f20f9c. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01297465-a7f20f9c
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 | 0.263 | 0.186 | 0.357 | wilson | |
| Risk in group 2 | 0.223 | 0.154 | 0.313 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0393 | -0.0785 | 0.157 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.18 | 0.722 | 1.92 | log | |
| Odds ratio, group 1 over group 2 | 1.24 | 0.65 | 2.36 | log | |
| Number needed to treat, for one more participant with the outcome on Gonal-f® Plus Pergoveris® than on Pergoveris® | 25.4 | 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® Plus Pergoveris® | Gonal-f® (follitropin alfa) 300 International Unit (IU) was administered subcutaneously once daily from stimulation day 1 (S1) to stimulation day 5 (S5) followed by subsequent daily administration of Pergoveris® (follitropin alfa and lutropin alfa) 300 IU subcutaneously starting from S6 until recombinant human chorionic gonadotropin (r-hCG) (Ovidrel®/Ovitrelle®) administration day (at least 1 follicles greater than or equal to (\>=) 18 millimeter \[mm\]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously. The dose of Pergoveris® was adjusted based upon the participant's ovarian response and according to the site's standard practice. | 26 | 99 | OG000 |
| Group 2 | Pergoveris® | Pergoveris® (follitropin alfa and lutropin alfa) 300 IU was administered subcutaneously once daily from S1 until r-hCG administration day (at least 1 follicles \>= 18 mm). On r-hCG (Ovidrel®/Ovitrelle®) day, 250 microgram of r-hCG was administered once subcutaneously. The dose of Pergoveris® was adjusted starting from S6 based upon the participant's ovarian response and according to the site's standard practice. | 23 | 103 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Participants With Treatment-emergent Adverse Events
- Description
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
- Time frame
- Day 1 up to days 15-20 post r-hCG day (end of stimulation cycle [approximately 11 days])
- Population
- Safety Population included all the randomized participants who had received at least 1 dose of Pergoveris® or Gonal-f®.
Source ClinicalTrials.gov
Trial
- Title
- PERgoveriS In Stratified Treatment for Assisted Reproductive Technique
- NCT number
- NCT01297465
- Phases
- PHASE3
- Conditions
- Assisted Reproductive Techniques, Reproductive Technology, Assisted
- Interventions
- Gonal-f®, Pergoveris®, Pergoveris®, Recombinant human chorionic gonadotropin (r-hCG)
- Lead sponsor
- Merck KGaA, Darmstadt, Germany
- Results first posted
- 2014-02-24
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01297465?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/NCT01297465-a7f20f9c