Comparison · NCT01927861-sae
0.033 mg/kg/Day vs 0.066 mg/kg/Day: 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. 0.033 mg/kg/Day vs 0.066 mg/kg/Day: serious adverse events. Trial comparisons, record NCT01927861-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01927861-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 | 0.36 | 0.202 | 0.555 | wilson | |
| Risk in group 2 | 0.385 | 0.224 | 0.575 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0246 | -0.271 | 0.228 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.936 | 0.458 | 1.91 | log | |
| Odds ratio, group 1 over group 2 | 0.9 | 0.289 | 2.8 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on 0.033 mg/kg/Day than on 0.066 mg/kg/Day | 40.6 | 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 | 0.033 mg/kg/Day | Participants received s.c. injection of NN-220, 0.033 mg/kg/day once daily for 234 weeks (104 weeks of pivotal phase + 104 weeks of extension phase + 26 weeks extended treatment phase). | 9 | 25 | EG000 |
| Group 2 | 0.066 mg/kg/Day | Participants received s.c. injection of NN-220, 0.066 mg/kg/day once daily for 234 weeks (104 weeks of pivotal phase + 104 weeks of extension phase + 26 weeks extended treatment phase). | 10 | 26 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Week 0 to week 234 (208 weeks treatment period + 26 weeks extended treatment period) + 7 days (follow-up period).
Source ClinicalTrials.gov
Trial
- Title
- Investigating the Long-term Efficacy and Safety of Two Doses of NN-220 (Somatropin) in Short Stature Due to Noonan Syndrome
- NCT number
- NCT01927861
- Phases
- PHASE3
- Conditions
- Genetic Disorder, Noonan Syndrome
- Interventions
- somatropin
- Lead sponsor
- Novo Nordisk A/S
- Results first posted
- 2019-10-14
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01927861?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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