Comparison · NCT00390858-sae
Children (<12 Years) vs Adolescents ( ≧12 Years): 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. Children (<12 Years) vs Adolescents ( ≧12 Years): serious adverse events. Trial comparisons, record NCT00390858-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00390858-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 | 0.2 | 0.0807 | 0.416 | wilson | |
| Risk in group 2 | 0.4 | 0.219 | 0.613 | wilson | |
| Risk difference, group 1 minus group 2 | -0.2 | -0.445 | 0.0819 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.5 | 0.179 | 1.4 | log | |
| Odds ratio, group 1 over group 2 | 0.375 | 0.0911 | 1.54 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Children (<12 Years) than on Adolescents ( ≧12 Years) | 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 | Children (<12 Years) | Deferasirox was given orally once daily, 30 minutes prior to breakfast. An initial daily dose of 10 mg/kg was used during the 1-year core study. In this 4-year extension study dose modifications of ± 5 or 10 mg/kg were based on safety parameters ( renal and hematology) and whether Liver Iron Concentration (LIC) and serum ferritin were increasing or decreasing | 4 | 20 | EG000 |
| Group 2 | Adolescents ( ≧12 Years) | Deferasirox was given orally once daily, 30 minutes prior to breakfast. An initial daily dose of 10 mg/kg was used during the 1-year core study. In this 4-year extension study dose modifications of ± 5 or 10 mg/kg were based on safety parameters ( renal and hematology) and whether Liver Iron Concentration (LIC) and serum ferritin were increasing or decreasing | 8 | 20 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years.
Source ClinicalTrials.gov
Trial
- Title
- A 4-year Extension Study to Core 1-year Study of Iron Chelation Therapy With Deferasirox in β-thalassemia Major Pediatric Patients With Transfusional Iron Overload.
- NCT number
- NCT00390858
- Phases
- PHASE2
- Conditions
- Transfusional Iron Overload, β-thalassemia Major, Pediatric Rare Anemia
- Interventions
- Deferasirox
- Lead sponsor
- Novartis Pharmaceuticals
- Results first posted
- 2011-08-15
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00390858?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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