Comparison · NCT01467661-sae
SPD422: Safety Analysis Set vs SPD422: Post-marketing Trial Safety Analysis Set: 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. SPD422: Safety Analysis Set vs SPD422: Post-marketing Trial Safety Analysis Set: serious adverse events. Trial comparisons, record NCT01467661-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01467661-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 | 0.396 | 0.276 | 0.531 | wilson | |
| Risk in group 2 | 0.0303 | 0.00537 | 0.153 | wilson | |
| Risk difference, group 1 minus group 2 | 0.366 | 0.194 | 0.503 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 13.1 | 1.84 | 92.7 | log | |
| Odds ratio, group 1 over group 2 | 21 | 2.66 | 166 | log | |
| Number needed to harm, for one more participant with a serious adverse event on SPD422: Safety Analysis Set than on SPD422: Post-marketing Trial Safety Analysis Set | 2.73 | 1.99 | 5.16 | 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 | SPD422: Safety Analysis Set | Included all enrolled participants who had taken at least 1 dose of SPD422 since enrolment into Study SPD422-308 (NCT01214915). | 21 | 53 | EG000 |
| Group 2 | SPD422: Post-marketing Trial Safety Analysis Set | Included all subjects in the safety analysis set who continued into the post-marketing part of study SPD422-309 (NCT01467661). | 1 | 33 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- From start of study treatment (SPD422308) up to 12 days after the last dose of investigational product
Source ClinicalTrials.gov
Trial
- Title
- Long-term Safety of SPD422 in Japanese Adults With Essential Thrombocythaemia
- NCT number
- NCT01467661
- Phases
- PHASE3
- Conditions
- Essential Thrombocythemia (ET)
- Interventions
- SPD422 (anagrelide hydrochloride)
- Lead sponsor
- Shire
- Results first posted
- 2016-06-08
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01467661?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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