Comparison · NCT01185704-sae
Day 1 Protocol vs Day 7 Protocol: 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. Day 1 Protocol vs Day 7 Protocol: serious adverse events. Trial comparisons, record NCT01185704-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01185704-sae
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 | 0.0308 | 0.00848 | 0.105 | wilson | |
| Risk in group 2 | 0.0615 | 0.0242 | 0.148 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0308 | -0.12 | 0.0527 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.5 | 0.0949 | 2.64 | log | |
| Odds ratio, group 1 over group 2 | 0.484 | 0.0855 | 2.74 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Day 1 Protocol than on Day 7 Protocol | 32.5 | 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 | Day 1 Protocol | Cetrotide® 0.25 milligram (mg) was administered subcutaneously once daily from Day 1 (Day 0 of stimulation period \[S0\]) along with Recombinant human follicle stimulating hormone (r-hFSH) at a dose between 75 and 187.5 international unit (IU) subcutaneously once daily from Day 2 (Day 1 of stimulation period \[S1\]) until recombinant human chorionic gonadotropin (r-hCG) administration day (at least 2 follicles greater than or equal to (\>=) 17 millimeter \[mm\]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously. | 2 | 65 | EG000 |
| Group 2 | Day 7 Protocol | Cetrotide® 0.25 mg was administered subcutaneously once daily from Day 7 (Day 6 of stimulation period \[S6\]) along with r-hFSH at a dose between 75 and 187.5 IU subcutaneously once daily from Day 2 (S1) until r-hCG administration day (at least 2 follicles \>= 19 mm). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously. | 4 | 65 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Day 1 up to end of study (15 days post last administration of study drug)
Source ClinicalTrials.gov
Trial
- Title
- Analysis of Two Therapeutic With Cetrotide® in Polycystic Ovarian (PCO) Women in Assisted Reproductive Technology (ART)
- NCT number
- NCT01185704
- Phases
- PHASE3
- Conditions
- Polycystic Ovarian Syndrome
- Interventions
- Cetrorelix acetate, Cetrorelix acetate, Recombinant Human Choriogonadotropin (r-hCG), Recombinant human follicle stimulating hormone (r-hFSH)
- Lead sponsor
- Merck KGaA, Darmstadt, Germany
- Results first posted
- 2013-07-03
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01185704?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/NCT01185704-sae