Comparison · NCT03169972-sae
Previously Treated Patients (PTPs) vs Previously Untreated Patients (PUPs): 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. Previously Treated Patients (PTPs) vs Previously Untreated Patients (PUPs): serious adverse events. Trial comparisons, record NCT03169972-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03169972-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 | 0.0163 | 0.00447 | 0.0574 | wilson | |
| Risk in group 2 | 0.0833 | 0.0149 | 0.354 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0671 | -0.338 | 0.0128 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.195 | 0.0191 | 2 | log | |
| Odds ratio, group 1 over group 2 | 0.182 | 0.0152 | 2.17 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Previously Treated Patients (PTPs) than on Previously Untreated Patients (PUPs) | 14.9 | 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 | Previously Treated Patients (PTPs) | Participants with hemophilia A who received Recombinant Factor VIII (FVIII) PEGylated (ADYNOVATE) intravenous Infusion as part of a routine medical care. Participants in this group were previously treated patients with Factor VIII deficiency (PTPs) who had 4 or more exposure days to other Factor VIII (FVIII) products. | 2 | 123 | EG000 |
| Group 2 | Previously Untreated Patients (PUPs) | Participants with hemophilia A who received Recombinant Factor VIII (FVIII) PEGylated (ADYNOVATE) intravenous Infusion as part of a routine medical care. Participants in this group were previously untreated patients with Factor VIII deficiency (PUPs) who had 3 or less previous exposure days to other Factor VIII (FVIII) products. | 1 | 12 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Up to 1 year for previously treated patients (PTPs) or up to 2 years for previously untreated patients (PUPs)
Source ClinicalTrials.gov
Trial
- Title
- ADYNOVATE Drug Use-Results Survey
- NCT number
- NCT03169972
- Phases
- Conditions
- Hemophilia A
- Interventions
- ADYNOVATE
- Lead sponsor
- Takeda
- Results first posted
- 2025-02-04
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03169972?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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