Comparison · NCT00627523-sae
Genotropin® vs Control: serious adverse events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
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ConductScience Library. Genotropin® vs Control: serious adverse events. Trial comparisons, record NCT00627523-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00627523-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 | 0.286 | 0.138 | 0.5 | wilson | |
| Risk in group 2 | 0.0909 | 0.0253 | 0.278 | wilson | |
| Risk difference, group 1 minus group 2 | 0.195 | -0.0436 | 0.418 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 3.14 | 0.712 | 13.9 | log | |
| Odds ratio, group 1 over group 2 | 4 | 0.706 | 22.7 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Genotropin® than on Control | 5.13 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: control.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Genotropin® | Participants received Genotropin® at a dose of 0.035 mg/kg/d for 24 months. The dose was calculated based on the actual body weight, and the closest dosing step of the 5 mg pen used. The starting dose for the first 2 weeks was 1/3 of the calculated dose. After 2 weeks the dose was increased to 2/3 of the calculated dose. After 4 weeks the daily dose was the dose calculated on body weight at randomization. | 6 | 21 | EG000 |
| Group 2 | Control | This group was the untreated control group and was not administered placebo. | 2 | 22 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Up to the participant's age of 49 to 55 months (Follow-up visit)
Source ClinicalTrials.gov
Trial
- Title
- Genotropin Treatment In Very Young Children Born Small For Gestational Age
- NCT number
- NCT00627523
- Phases
- PHASE3
- Conditions
- Infant, Small for Gestational Age
- Interventions
- Genotropin (PN-180,307) Somatropin, Control-no treatment
- Lead sponsor
- Pfizer
- Results first posted
- 2014-09-18
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00627523?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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