Comparison · NCT03136445-sae
Intervention Arm vs Control Arm: serious adverse events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
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ConductScience Library. Intervention Arm vs Control Arm: serious adverse events. Trial comparisons, record NCT03136445-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03136445-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 | 0.257 | 0.211 | 0.309 | wilson | |
| Risk in group 2 | 0.276 | 0.228 | 0.33 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0194 | -0.09 | 0.0514 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.93 | 0.712 | 1.21 | log | |
| Odds ratio, group 1 over group 2 | 0.905 | 0.63 | 1.3 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Intervention Arm than on Control Arm | 51.5 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: control.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Intervention Arm | Tranexamic acid (TXA). Dose schedule TXA 1g every eight hours IV or 1.5g every eight hours PO.~Tranexamic acid (TXA).: IV or oral preparation. IV tranexamic acid or Oral tablet of tranexamic acid. | 77 | 300 | EG000 |
| Group 2 | Control Arm | Placebo (saline) if administration is IV. Placebo tablet matched for appearance to TXA if oral.~Placebo: IV (saline) or oral placebo tablets | 82 | 297 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Mortality and Symptomatic thrombotic events were assessed up to day 120; SAEs up to day 60
Source ClinicalTrials.gov
Trial
- Title
- TRial to EvaluAte Tranexamic Acid Therapy in Thrombocytopenia
- NCT number
- NCT03136445
- Phases
- PHASE3
- Conditions
- Hematologic Neoplasms, Hemorrhage, Hematopoietic Stem Cell Transplantation
- Interventions
- Tranexamic acid (TXA)., Placebo
- Lead sponsor
- NHS Blood and Transplant
- Results first posted
- 2025-10-28
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03136445?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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