Comparison · NCT02141074-sae
Pre-prophylaxis vs Prophylaxis: 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. Pre-prophylaxis vs Prophylaxis: serious adverse events. Trial comparisons, record NCT02141074-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02141074-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 | 0.265 | 0.146 | 0.431 | wilson | |
| Risk in group 2 | 0.373 | 0.253 | 0.51 | wilson | |
| Risk difference, group 1 minus group 2 | -0.108 | -0.289 | 0.097 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.711 | 0.366 | 1.38 | log | |
| Odds ratio, group 1 over group 2 | 0.606 | 0.234 | 1.57 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Pre-prophylaxis than on Prophylaxis | 9.27 | 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 | Pre-prophylaxis | Participants received nonacog beta pegol 40 international units/kilogram (IU/kg) intravenous injection at intervals longer than a week on-demand for bleeding episodes until they were 24 months of age or until 20 exposure days (ED), whichever came first, in the main phase. Participants switched from pre-prophylaxis treatment to prophylaxis treatment no later than 24 months of age/20 ED, whichever came first. | 9 | 34 | EG000 |
| Group 2 | Prophylaxis | Participants who started with pre-prophylaxis were switched to prophylaxis no later than 24 months of age or upon reaching 20EDs, whichever came first. These participants that switched from pre-prophylaxis and other participants who started directly on prophylaxis since visit 1 received once weekly dosing of nonacog beta pegol 40 IU/kg intravenous injection in the main phase, extension phase, and until the end of treatment. | 19 | 51 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Up to Week 434
Source ClinicalTrials.gov
Trial
- Title
- Safety and Efficacy of Nonacog Beta Pegol (N9-GP) in Previously Untreated Patients With Haemophilia B
- NCT number
- NCT02141074
- Phases
- PHASE3
- Conditions
- Congenital Bleeding Disorder, Haemophilia B
- Interventions
- nonacog beta pegol
- Lead sponsor
- Novo Nordisk A/S
- Results first posted
- 2023-12-29
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02141074?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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