Comparison · NCT01185782-sae
SJ-0021 vs u-hFSH: 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. SJ-0021 vs u-hFSH: serious adverse events. Trial comparisons, record NCT01185782-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01185782-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 | 0.00775 | 0.00137 | 0.0426 | wilson | |
| Risk in group 2 | 0.00758 | 0.00134 | 0.0417 | wilson | |
| Risk difference, group 1 minus group 2 | 0.000176 | -0.0345 | 0.0356 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.02 | 0.0647 | 16.2 | log | |
| Odds ratio, group 1 over group 2 | 1.02 | 0.0633 | 16.5 | log | |
| Number needed to harm, for one more participant with a serious adverse event on SJ-0021 than on u-hFSH | 5,680 | 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 | SJ-0021 | SJ-0021 (recombinant follitropin alfa) was administered subcutaneously (s.c.) at a starting dose of 75 International Unit (IU)/day which was to be followed by incremental doses of 37.5 IU on Days 8, 15 and 22 if the mean dominant follicle diameter was less than 11 mm. The maximum duration of treatment was 28 days. | 1 | 129 | EG000 |
| Group 2 | u-hFSH | Urinary human follicle stimulating hormone (u-hFSH), a purified pituitary gonadotropin, was administered s.c. at a starting dose of 75 IU/day which was to be followed by incremental doses of 37.5 IU on Days 8, 15 and 22 if the mean dominant follicle diameter was less than 11 mm. The maximum duration of treatment was 28 days. | 1 | 132 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
AEs were collected on an ongoing basis from day of written informed consent. All new AEs must be recorded until the final post-treatment examination, on Day 35-42 of the post-treatment assessment period.
Source ClinicalTrials.gov
Trial
- Title
- SJ-0021 (Gonalef®) Versus Purified Pituitary Gonadotropin (Fertinorm-P®) for Ovulation Induction in Japanese Infertile Women
- NCT number
- NCT01185782
- Phases
- PHASE3
- Conditions
- Infertility, Ovulation Induction
- Interventions
- Gonalef® (Follitropin alfa), Purified pituitary gonadotropin (Fertinorm-P®)
- Lead sponsor
- Merck KGaA, Darmstadt, Germany
- Results first posted
- 2012-02-24
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01185782?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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