Comparison · NCT03764618-sae
Fostamatinib vs Placebo: 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. Fostamatinib vs Placebo: serious adverse events. Trial comparisons, record NCT03764618-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03764618-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 | 0.333 | 0.214 | 0.479 | wilson | |
| Risk in group 2 | 0.378 | 0.251 | 0.524 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0444 | -0.233 | 0.149 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.882 | 0.505 | 1.54 | log | |
| Odds ratio, group 1 over group 2 | 0.824 | 0.347 | 1.95 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Fostamatinib than on Placebo | 22.5 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Fostamatinib | Initial dose is 100 mg PO bid. At week 4 dose will be increased to fostamatinib 150 mg PO bid if subjects have adequately tolerated the study drug in the opinion of the Investigator.~Fostamatinib disodium: Fostamatinib (100mg PO bid or 150 mg PO bid)~The dose may be reduced at any time to a dose as low as fostamatinib 100 mg PO qd or matching placebo if dose limiting adverse events are observed. | 15 | 45 | EG000 |
| Group 2 | Placebo | Initial dose is 100 mg PO bid. At week 4 dose will be increased to placebo 150 mg PO bid if subjects have adequately tolerated the study drug in the opinion of the Investigator.~Placebo: Placebo | 17 | 45 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Up to 30 weeks (-28 days screening, 24 weeks treatment, 2 weeks post treatment follow-up)
Source ClinicalTrials.gov
Trial
- Title
- A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Study of Fostamatinib Disodium in the Treatment of wAIHA
- NCT number
- NCT03764618
- Phases
- PHASE3
- Conditions
- Warm Antibody Autoimmune Hemolytic Anemia
- Interventions
- Fostamatinib disodium, Placebo
- Lead sponsor
- Rigel Pharmaceuticals
- Results first posted
- 2023-05-25
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03764618?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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