Comparison · NCT02352753-sae
Denosumab 6-Month Dosing Regimen vs Denosumab 3-Month Dosing Regimen: 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. Denosumab 6-Month Dosing Regimen vs Denosumab 3-Month Dosing Regimen: serious adverse events. Trial comparisons, record NCT02352753-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02352753-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 | 0.34 | 0.27 | 0.418 | wilson | |
| Risk in group 2 | 0.2 | 0.118 | 0.318 | wilson | |
| Risk difference, group 1 minus group 2 | 0.14 | 0.00267 | 0.253 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.7 | 0.978 | 2.95 | log | |
| Odds ratio, group 1 over group 2 | 2.06 | 1.01 | 4.21 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Denosumab 6-Month Dosing Regimen than on Denosumab 3-Month Dosing Regimen | 7.15 | 3.95 | 375 | from the risk difference interval |
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 | Denosumab 6-Month Dosing Regimen | Participants received denosumab 1 mg/kg (up to a maximum of 60 mg) subcutaneously every 6 months (Q6M) for up to 36 months. | 52 | 153 | EG000 |
| Group 2 | Denosumab 3-Month Dosing Regimen | Participants were dose adjusted from Q6M to every 3 months (Q3M) after early efficacy and PK data were analyzed. Participants enrolled and still receiving denosumab were transitioned from Q6M to Q3M dosing schedule. Participants could transition to Q3M dosing schedule up to and including the date they attended for their Month 36 visit under the Q6M dosing regimen. Those participants received denosumab during the Q3M dosing regimen for 12 months. Participants who transitioned to Q3M at month 18 of the Q6M dosing regimen received denosumab Q3M for up to 18 months. | 12 | 60 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- 6QM dosing regimen: Day 1 up to 36 months 3QM dosing regimen: Day 1 up to 24 weeks after last dose (median duration of treatment was 253 days)
Source ClinicalTrials.gov
Trial
- Title
- Multicenter,Single-arm Study to Evaluate Efficacy, Safety, & Pharmacokinetics of Denosumab in Children w/ OI
- NCT number
- NCT02352753
- Phases
- PHASE3
- Conditions
- Osteogenesis Imperfecta
- Interventions
- Denosumab
- Lead sponsor
- Amgen
- Results first posted
- 2022-12-28
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02352753?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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